PENGUIN THERMA-LINER

Additional Manufacturer Narrative

COM-PAC RECEIVED 10 THERMA-LINER BAGS FROM AMEDA, INC. (CUSTOMER) AND VERIFIED THAT THERE WERE SMALL HOLES IN THE WALLS OF THE INNER BAGS. THERE WAS NO LEAKAGE FROM ONE OF THREE BAGS RECEIVED FROM MEMORIAL HERMANN HEALTH. COM-PAC REVIEWED QA INSPECTION LOGS FOR THE MANUFACTURER DATES INDICATED AND DETERMINED THERE WERE NO REJECTED UNITS FOR LEAKAGE. AMEDA, INC. RANDOMLY SELECTED A CARTON OF 50 UNITS FROM THEIR INVENTORY AND RANDOMLY SELECTED 10 UNITS FROM THAT CARTON. THE BAG'S WATER COMPARTMENT WAS FILLED WITH WATER AND LEANED VERTICALLY AGAINST THE WALL. MOISTURE WAS OBSERVED UNDER ONE OF THE TEN BAGS THE NEXT MORNING. LOCATION OF LEAK WAS NOT VERIFIED. AMEDA, INC. SENT 50 BAGS TO COM-PAC FOR TESTING. COM-PAC CONDUCTED INVERTED WATER LEAK TESTING AND INTERNAL (VACUUM) PRESSURE ON ALL 50 RETURNED BAGS. WATER COMPARTMENT BAGS WERE FILLED WITH 6 OZ WATER AND HUNG SUCH THAT WATER IMPINGED ON EACH OF 2 SIDE SEALS, THE BOTTOM FOLD AND ZIPPER FOR 30 MINUTES. NO WATER LEAKAGE WAS INDICATED. ABSORBENT MEDIA WHICH WAS PLACED INTO INNER BAG COMPARTMENT INDICATED NO INTERNAL LEAKAGE. THE BAG WHICH AMEDA INDICATED LEAKED SHOWED NO EVIDENCE OF LEAKAGE DURING COM-PAC TESTING.

Description of Event or Problem

(B)(6), RISK MANAGER AT (B)(6) SUBMITTED A SUS VOLUNTARY EVENT REPORT TO THE FDA ON 12/29/2016 AND WAS RECOVERED BY THE FDA ON 01/04/2017. (MW5067021) SUBMISSION OF THE MEDWATCH WAS FOR THE ISSUE OF LEAKING WATER FROM THE EXTERNAL JACKET INTO THE DRY INTERNAL COMPARTMENT THAT HOUSES THE BREAST MILK FEEDING CONTAINER OF THE THERMA-LINER BAGS USED IN THE AMEDA PENGUIN NUTRITIONAL WARMER SYSTEM. IF THIS EVENT OCCURS, THE INTERNAL COMPARTMENT IS COMPROMISED WHICH CAN RESULT IN POTENTIAL CONTAMINATION OF THE BABIE'S FOOD SOURCE. THERE WERE NO BABIES HARMED DUE TO THE LEAKING THERMA-LINERS. THE AMEDA SALES REPRESENTATIVE FOR THIS REGION CONSULTED WITH THE NICU MANAGER AT (B)(6) ON 02/02/2017 AFTER AMEDA WAS NOTIFIED OF THIS MW SUBMISSION BY THE FDA. LEAKING THERMA-LINER BAGS WERE OBTAINED FROM THIS FACILITY AND OVERNIGHT SHIPPED TO AMEDA, INC. FOR FURTHER INVESTIGATION BY AMEDA AND COM-PAC, THE MANUFACTURER OF THERMA-LINER BAGS FOR THE PENGUIN NUTRITIONAL WARMER.