Description of Event or Problem · 0
INVESTIGATION: ON 09/02/2025, BIOTISSUE DISTRIBUTOR (B)(6) RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL REGARDING A PROKERA SLIM (PKS) DEVICE. UPON OPENING THE SECONDARY PACKAGING, THE PRIMARY PACKAGING WAS REPORTED BY THE CUSTOMER TO BE PARTIALLY SEALED; THE TRAY AND LID WERE NOT FULLY SEALED, AND THE PRODUCT WAS NOT USED. THE DEVICE WAS RETURNED ON 10/10/2025 FOR INSPECTION. INVESTIGATION FINDINGS: RETURNED SAMPLE: THE LID WAS PARTIALLY SEALED AT THE TRAY CENTER; PKS DEVICE PRESENT WITH HOLD-DOWN BUT NO STORAGE SOLUTION. SEAL INDENTATIONS INDICATED THE UNIT EXPOSURE TO SEALING PROCESS. LOT REVIEW: PROKERA SLIM LOT BTDS2024-10238 RECORDS CONFIRMED COMPLIANCE WITH SPECIFICATIONS. ONE UNRELATED NONCONFORMANCE (DOUBLE LID) DOCUMENTED; NO OTHER DEFECTS OR COMPLAINTS REPORTED FOR THIS LOT. COMPLAINT HISTORY: NO SIMILAR ISSUES REPORTED IN PAST 5 YEARS. DEFECT WOULD LIKELY BE DETECTED DURING HANDLING DUE TO EXPOSURE/LEAKAGE. EQUIPMENT REVIEW: HEAT SEALER (MEDPACK SEALER ID 000910) HISTORY SHOWED NO ISSUES DURING LOT PRODUCTION; LATER MAINTENANCE ON THE SEALER WAS DOCUMENTED BUT WAS FOUND TO BE UNRELATED TO COMPLAINT. PROCESS AND COMPONENT INSPECTIONS: NO DEVIATIONS FOUND; SEAL TESTING COULD NOT REPLICATE DEFECT. STORAGE CONDITIONS: CONFIRMED COMPLIANT AT DISTRIBUTOR AND CUSTOMER SITES. ROOT CAUSE COULD NOT BE CONFIRMED. RETURNED UNIT WAS PARTIALLY SEALED, BUT MANUFACTURING AND PACKAGING REVIEW FOUND NO SYSTEMIC RISK. HANDLING DURING INTERNATIONAL SHIPMENT MAY HAVE CONTRIBUTED, THOUGH INSUFFICIENT EVIDENCE EXISTS.