WARMERS, INFANT HEEL W/TABS

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS A VIABLE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. THE NUMBER PROVIDED (CH42SP10604) IS THE POUCH MATERIAL NUMBER AND NOT A LOT NUMBER FOR THE PRODUCT. BECAUSE THERE WAS NO VIABLE LOT NUMBER, A DATE OF MANUFACTURE COULD NOT BE DETERMINED. HOWEVER, AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. A SAMPLE POUCH WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. A VISUAL INSPECTION OF THE PRODUCT WAS NOT ABLE TO IDENTIFY A SECTION OF THE POUCH WHERE IT BURST. AIR WAS USED TO EXPAND THE POUCH WITH THE INTENT OF LOCATING AN OPEN SECTION OF THE POUCH TO INDICATE WHERE THE POUCH BURST. THE POUCH HELD THE AIR. THERE WAS NO SECTION OF THE POUCH WHICH WAS OPEN INDICATING A BURST POUCH. THE REPORTED ISSUE COULD NOT BE CONFIRMED AT THIS TIME. HOWEVER, IT SHOULD BE NOTED THAT THE RETURNED SAMPLE WAS FULLY ACTIVATED UPON RECEIPT. IT IS IMPORTANT TO NOTE THAT A SERIES OF TESTS ARE PERFORMED DURING EVERY LOT OF PRODUCTION. MORE SPECIFICALLY, INSPECTIONS ARE PERFORMED TO TEST THE SEAL STRENGTH FOR BOTH THE INNER SEAL, WHERE THE PRODUCT WOULD ACTIVATE AND THE OUTER SEAL. DURING THE TEST, THE POUCH IS FIRST ACTIVATED, AND THE INNER SEAL IS BROKEN. THE POUCH IS THEN PLACED BETWEEN TWO PLATES. THE POUCH IS COMPRESSED UNTIL THE PRESSURE REQUIRED PER THE PROCEDURE IS REACHED, 350 LBS MINIMUM. THE POUCH IS LEFT TO DWELL IN THE MACHINE FOR 20 SECONDS, USING A CALIBRATED STOPWATCH TO TIME IT. AFTER THE DWELL TIME, THE POUCH IS REMOVED AND VISUALLY INSPECTED FOR LEAKS OR SPREADING OF THE SEAM. A POUCH WITH ANY ISSUES WOULD BE REJECTED AT THIS TIME AND THE MACHINE ADJUSTED. IF THE POUCH PASSES THE DWELL TEST IT IS RETURNED TO THE MACHINE AND THE POUCH IS THEN COMPRESSED UNTIL THE POUCH BREAKS OR REACHES OVER 1000 POUNDS. THE VALUE IS THEN RECORDED. AS PART OF CONTINUOUS IMPROVEMENTS CORRECTIVE AND PREVENTATIVE ACTION (CAPA) PLANS HAVE BEEN OPENED FOR ISSUES REGARDING BOTH BURST POUCHES AND PRE-ACTIVATION ISSUES. THE CAPA FOR BURST POUCHES AIMS TO INVESTIGATE SEALING AND MATERIAL ISSUES ON THE LINE. IN ADDITION, QUALITY ALERTS HAVE BEEN ISSUED TO THE APPROPRIATE MANUFACTURING PERSONNEL TO HEIGHTEN AWARENESS AND A 24-HOUR PRODUCT HOLD TIME IN PLACE. WE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS.

Additional Manufacturer Narrative

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THE NURSE HAD THE HEEL WARMER BURST ON THEM. THERE WAS NO HARM TO THE NURSE OR PATIENT.