PENCAN®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: FOREIGN OBJECT OBSERVED IN THE SYRINGE. NO INJURY REPORTED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). ONE (1) SYRINGE WITH PACKAGING, AND ONE (1) PHOTOGRAPH WERE PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE SAMPLE AND PHOTOGRAPH CONFIRMED AN UNKNOWN SUBSTANCE ON THE PLUNGER INSIDE THE BARREL OF THE SYRINGE. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED DEFECT WAS CONFIRMED. THE SUPPLIER WAS PROVIDED WITH PHOTOGRAPHS FOR THEIR INVESTIGATION. THE SUPPLIER CONFIRMED THAT THE NONCONFORMANCE FOREIGN MATERIAL IS LIKELY A PIECE OF CORRUGATED PAPER. THE SUPPLIER STATED THAT ALL AREAS OF THE PRODUCTION PROCESS WERE EVALUATED. THERE WAS NO PROCESS OBSERVED WHERE CONTAMINATION COULD GET INTO BARREL OR PISTON DURING THE MANUFACTURING PROCESS. THE SUPPLIER NOTED THAT FOR THIRD PARTY PRODUCT INSPECTION, EMPLOYEES WOULD UNPACK THE PRODUCT AND SEND PRODUCT BACK FROM THE WAREHOUSE INTO THE CLEAN AREA FOR INSPECTION BY USING THE FINISHED GOODS, EXIT ONLY, CONVEYOR. THIS ACTION BYPASSES CLEANLINESS REVIEW PRIOR TO GOING INTO THE CLEAN ROOM. A PIECE OF CORRUGATED PAPER MAY HAVE BEEN ON THE PE BAG WHILE BEING TRANSFERRED BACK INTO THE CLEAN AREA. THE CORRUGATED PAPER MAY THEN HAVE FALLEN INTO THE SYRINGE DURING PRODUCT HANDLING FOR THE INSPECTION. THE SUPPLIER UPDATED THEIR PROCEDURE TO CLEARLY STATE THAT MATERIALS GOING INTO THE CLEANROOM AREA MUST GO THROUGH THE INCOMING AIR LOCK ROOM, WHERE THEY ARE TO BE INSPECTED FOR FOREIGN MATERIAL BEFORE BEING BROUGHT INTO THE CLEANROOM. THE PERSONNEL WILL RECEIVE TRAINING ON PROPERLY USING THE AIR LOCK ROOM WHEN BRINGING PRODUCT BACK INTO THE CLEAN ROOM FOR THIRD PARTY INSPECTIONS. ADDITIONALLY, A REVIEW OF APPLICABLE PROCEDURES AND INSPECTIONS BY PERSONNEL WAS CONDUCTED. TRAINING RECORDS WERE REVIEWED FOR THE INSPECTORS INVOLVED WITH THE REPORTED LOT AND INSPECTORS WERE APPROPRIATELY TRAINED TO THE INCOMING SPECIFICATION. IN PROCESS INSPECTIONS ARE PERFORMED, ON A ROUND-BASED SAMPLING PLAN AND INCLUDE INSPECTIONS FOR FOREIGN MATERIAL FLUID PATH/NON FLUID PATH, DAMAGE, AND DISCOLORATION. LASTLY ALL FINISHED GOOD KITS ARE INSPECTED PER FINAL PRODUCT SPECIFICATION, CONVENIENCE KITS, FOR FOREIGN MATERIAL FLUID PATH. ALL INSPECTIONS COMPLETED WERE FOUND WITH PASSING RESULTS. NO DEVIATIONS WERE FOUND IN THE RECEIVAL OF THE SUPPLIER PURCHASED PART OR THE MANUFACTURING PROCESS OF THE FINISHED GOOD KIT ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCE'S WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. ADDITIONALLY, A ONE-YEAR HISTORICAL SEARCH WAS COMPLETED ON THE REPORTED FINISHED GOOD ITEM AND EVALUATED PART. NO ADDITIONAL COMPLAINTS REGARDING FOREIGN MATERIAL HAVE BEEN REPORTED AGAINST EITHER MATERIAL. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.