"WARMERS, INFANT HEEL W/TABS"

Additional Manufacturer Narrative

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE HEEL WARMER BROKE AND LEAKED ON THE INFANT'S BED. THERE WAS NO HARM TO THE PATIENT OR STAFF.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. ALL DHRS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO THE RELEASE OF PRODUCT. THERE WERE NO SAMPLES RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION OF THE REPORTED CONDITION COULD NOT BE MADE. AN INVESTIGATION INTO ACTIVITIES ASSOCIATED WITH THE MANUFACTURE OF THE PRODUCT SHOWED THAT THE MATERIAL ALIGNMENT IS THE MOST LIKELY CAUSE OF THE REPORTED CONDITION. THE CLEAR LINER AND WHITE LINER SHOULD BE LINED UP TOGETHER AND SEALED BY THE SEALER BARS. IF THE MATERIAL IS NOT LINED UP CORRECTLY IT CAN CAUSE A WEAK SEAL, AS THERE WOULD NOT BE ENOUGH MATERIAL TO COMPLETE A FULL SEAL. IT IS NOT ALWAYS POSSIBLE TO IMMEDIATELY SEE THE ISSUE AS ONE OF THE MATERIALS IS CLEAR. IT HAS BEEN DETERMINED THERE ARE INDICATORS WITHIN THE MANUFACTURING PROCESS WHICH WILL ASSIST IN VERIFYING THE MATERIALS ARE LINED UP CORRECTLY. IT IS ALSO 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. THE RESULTS OF THE MANUFACTURING FACILITY INVESTIGATION WERE ABLE TO IDENTIFY THE MOST PROBABLE CAUSE OF THE ISSUE IS ASSOCIATED WITH THE MANUFACTURING PROCESS. A QUALITY ALERT HAS BEEN ISSUED FOR AWARENESS OF THE INDICATORS OF MIS-ALIGNED MATERIAL. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO VERIFY THE ROOT CAUSE AND DETERMINE ACTIONS TO PREVENT RECURRENCE OF THE ISSUE. THE MANUFACTURING SITE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS.