Inspect to Protect: Manufacturing Defect in Proseal Laryngeal Mask Airway

The ProSeal Laryngeal Mask Airway (PLMA) is widely used for airway management during general anesthesia. It offers better sealing pressure, reduced aspiration risk, and ease of insertion compared with traditional LMAs. Its design allows positive pressure ventilation, making it suitable for both elective and emergency procedures. However, any manufacturing defect can jeopardize airway safety and clinical outcomes. A 3-month-old male infant weighing 5 kg, full-term and healthy, was scheduled for herniotomy under general anesthesia. Preanesthetic evaluation was unremarkable. The plan included general anesthesia with a supraglottic airway device (PLMA, Size 1) and caudal block. The device was checked for cuff integrity before use. Induction was achieved with propofol (4 mg/kg IV), fentanyl (2 μg/kg IV), and sevoflurane in oxygen. After confirming jaw relaxation, the PLMA (Size 1) was inserted, inflated, and secured. Pressure-controlled ventilation was initiated using a closed silicone circuit to ensure adequate tidal volume and oxygenation. Shortly after insertion, a weak area was noticed at the airway tube–connector junction, accentuated by the circuit's weight (Figure 1), raising concern about possible breakage. Closer inspection revealed a fragile spot at the proximal end near the connector that could have caused ventilation failure if torn. To prevent this, the anesthesiologist reinforced the site with adhesive tape. Oxygen saturation, capnography, and end-tidal CO2 were continuously monitored. The infant remained stable with SpO2 > 98%, and surgery lasted 30 min uneventfully under sevoflurane (2%–3%) with 50% nitrous oxide in oxygen. After removal, gentle pressure on the weakened joint caused it to tear, confirming the high risk of intraoperative failure had the defect gone unnoticed. Post-procedure inspection revealed a visible tear after minimal handling. As five Size 1 PLMAs had recently been procured from a single lot, all were examined. Alarmingly, each device in batch LOT NHAA6J showed the same weak area at the proximal end, compromising the integrity of the entire batch (Figure 2). One device was already torn within its package. The batch was immediately reported and returned to the manufacturer, Teleflex Incorporated, Wayne, Pennsylvania, USA, for investigation. The company acknowledged the defect, initiated a production-line review, and committed to issuing replacements. This event highlights serious concerns regarding airway device safety in pediatric anesthesia, where even minor defects can have catastrophic consequences. Jangra et al. reported a lumen defect in a Laryngeal Mask Silken causing partial obstruction [1], and von Ungern-Sternberg et al. described the detachment of a cuff weld near the LMA tip [2]. In infants, such malfunctions can rapidly compromise ventilation and lead to hypoxia. In this case, the fragile proximal end of the ProSeal LMA posed a significant hazard but was detected early and temporarily reinforced, ensuring safe ventilation. Had rupture occurred intraoperatively, ventilation failure and hypoxemia could have resulted. The discovery that an entire lot was defective raises major concerns about manufacturing quality control. Such uniform weakness indicates lapses in material inspection or bonding during production. Manufacturers of airway devices must adopt stringent multilayer quality assurance protocols, including random sampling, mechanical stress testing, and post-market surveillance to detect faults before distribution [3]. Hospitals should maintain systems for device traceability and lot-wise reporting to enable prompt recall if similar defects arise. This case emphasizes meticulous pre-use inspection of airway devices, even when newly purchased from reputable suppliers. Every component—including cuff, connector, and tube—should be tested for air leaks and structural integrity. Routine checks should form institutional policy rather than rely solely on manufacturer certification. Clinicians must be trained to identify subtle abnormalities such as weak junctions, discoloration, or irregular tube thickness. When a fault is suspected, an alternative airway device should be readily available. Temporary measures like adhesive reinforcement may serve as emergency solutions but cannot replace proper evaluation or preparation of backups. Providers should always maintain an alternative airway plan—such as endotracheal intubation or a secondary LMA—in anticipation of unexpected failure. Equipment malfunctions must be documented and reported to biomedical teams and manufacturers to strengthen safety feedback loops [4]. Continuous communication between clinicians and manufacturers is essential. Early reporting and prompt manufacturer response, as shown by Teleflex Incorporated, are vital for corrective action and prevention of recurrence. Such collaboration fosters safer clinical practice and reinforces post-marketing quality assurance of anesthesia equipment. In conclusion, this case underscores the critical need for thorough inspection and vigilance when using airway devices in pediatric anesthesia. Timely recognition and management of a defective ProSeal LMA (Size 1) averted a potentially serious airway event. Regular equipment checks, contingency planning, and stringent manufacturing oversight remain fundamental to patient safety. Heightened awareness regarding device reliability must continue to guide safe anesthetic practice. This report complies with the CARE checklist under the EQUATOR guidelines. Institutional Review Board approval was not required for this single case report. The authors have nothing to report. Written informed consent was obtained from the patient's guardian. The information is anonymized, and no identifiable images are included. The authors declare no conflicts of interest. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.