WARMERS, INFANT HEEL W/TABS

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF THE PRODUCT. SINCE A LOT NUMBER WAS NOT PROVIDED AND THE RETURNED SAMPLE DOES NOT HAVE A LOT NUMBER, INFORMATION SUCH AS THE TEST RESULTS, QUANTITY MANUFACTURED, AND DATE OF MANUFACTURE COULD NOT BE DETERMINED. THE CUSTOMER RETURNED ONE HEEL WARMERS FOR ANALYSIS. A VISUAL INSPECTION OF THE SAMPLE SHOWS THE BOTTOM OF THE POUCH IS OPEN ABOVE THE SEAL. THE MATERIAL AROUND THE BREAK IS CURLED AND IT WAS NOT POSSIBLE TO DO A MATERIAL THICKNESS CHECK. THERE DOES NOT APPEAR TO BE ANY BURN MARKS OR OTHER INDICATORS SHOWING A SEALER ISSUE. THERE ARE VISUAL SIGNS OF AN ISSUE BESIDES THE BROKEN SEAL. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE CUSTOMER RETURNED SAMPLE, A LIKELY CONTRIBUTOR FOR THIS ISSUE IS AS THE VERTICAL SEALER BAR IS SEALING THE TOP OF TWO CONSECUTIVE POUCHES, THERE COULD BE A LOCALIZED WEAK REGION JUST PRIOR TO THE MIDPOINT OF THE VERTICAL SEALER BAR CAUSING AN INCOMPLETE SEAL. ADDITIONALLY, THERE COULD HAVE BEEN SOME TYPE OF BUILDUP ON THE SEALER BARS THAT WOULD CAUSE A LOCALIZED WEAK SPOT. RELATIVE TO THE ISSUE REPORTED BY THE CUSTOMER, PRESSURE WAS APPLIED BY THE CLINICIAN AND THIS AREA OF THE POUCH BROKE OPEN. THE RESULTS OF THE MANUFACTURING FACILITY INVESTIGATION WERE ABLE TO IDENTIFY A LOCALIZED AREA OF THE POUCH THAT WAS THE LIKELY AREA WHERE THE POUCH CONTENTS LEAKED OUT. A REVIEW OF MAINTENANCE ACTIVITY NOTED THAT THE SEALER BARS WERE DIRTY AND WORN AND WERE THEREFORE CLEANED AND REPLACED. THE OPERATOR¿S PREVENTIVE MAINTENANCE (PM) GUIDE HAS BEEN UPDATED TO INCLUDE A VISUAL INSPECTION AND CLEANING OF ALL SEALER BARS AND DIES EVERY MONTH DURING REGULAR PM¿S. WE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS. THE RESULTS OF THE MANUFACTURING FACILITY INVESTIGATION WERE ABLE TO IDENTIFY A LOCALIZED AREA OF THE POUCH THAT WAS THE LIKELY AREA WHERE THE POUCH CONTENTS LEAKED OUT OF. A REVIEW OF MAINTENANCE ACTIVITY NOTED THAT THE SEALER BARS WERE DIRTY AND WORN AND WERE THEREFORE CLEANED AND REPLACED. THE OPERATOR¿S PREVENTIVE MAINTENANCE (PM) GUIDE HAS BEEN UPDATED TO INCLUDE A VISUAL INSPECTION AND CLEANING OF ALL SEALER BARS AND DIES EVERY MONTH DURING REGULAR PM¿S. WE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS. AS PART OF CONTINUOUS IMPROVEMENTS, A FORMAL INVESTIGATION HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT THE APPROPRIATE CORRECTIVE ACTIONS TO PREVENT THE RECURRENCE OF THE REPORTED ISSUE. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

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.

Description of Event or Problem

CUSTOMER REPORTS: THE RN SQUEEZED THE BAG TO PUNCTURE THE INNER BLADDER OF THE HEEL WARMER. THE OUTER BAG BROKE SPRAYING CONTENTS ON THE STAFF MEMBER CAUSING SKIN REDNESS AND BURNING ON THE FACE, NECK, AND CHEST. IT DOES NOT APPEAR THAT THERE WAS PERMANENT SCARRING.