PORTEX ANESTHSIA BREATHING BAG, 3L, 22MM

Additional Manufacturer Narrative

B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. D4: EXACT LOT NUMBER, EXPIRATION DATE, UDI, AND H4: MANUFACTURE DATE CANNOT BE DETERMINED AS 2 POSSIBLE LOT NUMBERS HAVE BEEN IDENTIFIED. 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, MAKING IT UNUSABLE." THIS OCCURRED UPON REMOVAL FROM PACKAGE. NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. POSSIBLE LOT NUMBERS: 4400497 OR 4403670.

Additional Manufacturer Narrative

H3 AND H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: FIVE PHOTOS WERE INCLUDED FOR EVALUATION; A HOLE WAS OBSERVED IN THE BAG BREATHING. ONE (1) SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGE. PER VISUAL INSPECTION, HOLE WAS DETECTED IN BREATHING BAG, COMPLAINT WAS CONFIRMED. THIS ISSUE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS TAKEN ACCORDINGLY TO DETERMINE THE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR BOTH POSSIBLE REPORTED LOT NUMBERS, SHOW THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH EITHER LOT OF PRODUCTS.