PORTEX ANESTHSIA BREATHING BAG, 3L, 22MM

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT "THE ANESTHESIA BAG HAD A HOLE AND LEAKED, SO IT COULD NOT BE USED." THIS OCCURRED UPON REMOVAL FROM PACKAGE. NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. REPORTED ITEM NUMBER: CA24E0/4P6/000JP AND REPORTED LOT NUMBER: 231228. RECEIVED COMPONENT ITEM NUMBER: (B)(4) AND RECEIVED COMPONENT LOT NUMBER: 4442745.

Additional Manufacturer Narrative

H3 AND H6. EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE (1) DEVICE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGE. FIVE PHOTOS WERE INCLUDED FOR EVALUATION; A HOLE WAS OBSERVED IN THE BAG BREATHING. PER VISUAL INSPECTION, HOLE WAS DETECTED IN BREATHING BAG, COMPLAINT WAS CONFIRMED. THE CAUSE WAS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. THE COMPLAINT FAULT HAS BEEN ESCALATED TO ADDRESS A FULL ROOT CAUSE INVESTIGATION.