DESIGN OPTIONS®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) UNUSED SYRINGE WITHOUT PACKAGING WAS PROVIDED FOR EVALAUTION. VISUAL EVALAUTION OF THE SAMPLE CONFIRMED A SYRINGE WITH A PIECE OF METAL WIRE EMBEDDED GREATER THAN 0.5MM2 INSIDE THE BARREL OF THE SYRINGE. BASED ON THE INVESTIGATION FINDING, THE REPORTED DEFECT WAS CONFIRMED. THE SYRINGE IS A PURCHASED PART FROM GERMANY; NO B. BRAUN USA EQUIPMENT WAS RELATED TO THIS DEFECT. 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 PER PROCEDURE (KITS), 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-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. ALL COMPONENTS FROM THE RETAIN SAMPLE FROM THE REPORTED LOT NUMBER WERE VISUALLY INSPECTED FOR ANY CONTAMINATION. THERE WERE NO PIECES OF WIRE OR ANY PARTICULATES SEEN IN THE SYRINGE OR ANY OTHER COMPONENT OF THE TRAY. 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.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED; HOWEVER, TWO (2) PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. VISUAL EVALUATION OF BOTH PHOTOGRAPHS CONFIRMS A 3ML SYRINGE WITH A PIECE OF METAL WIRE INSIDE THE BARREL OF THE SYRINGE. BASED ON VISUAL FINDINGS, THE SAMPLE WAS NOT WITHIN INTERNAL SPECIFICATION; THEREFORE, THE REPORTED DEFECT WAS CONFIRMED. THE NEEDLE IS A PURCHASED PART FROM B. BRAUN GERMANY AND ALL INFORMATION HAS BEEN FORWARDED TO THE SUPPLIER FOR FURTHER INVESTIGATION. ALTHOUGH THE PHOTOS CONFIRM AN UNKNOWN WIRE LIKE PIECE OF METAL IN THE BARREL OF THE SYRINGE, THE PROVIDED PICTURE DOES NOT OFFER THE DETAILS NECESSARY TO DETERMINE ANY ROOT CAUSE AT THIS TIME. B. BRAUN KITS ARE PACKAGED ACCORDING TO BLUEPRINT SPECIFICATIONS, WHILE INSPECTING FOR ANY DEFECTS OR DEVIATIONS FROM DRAWING (E.G. EMBEDDED PARTICLES, DIRT, MISSING OR INCORRECTLY ASSEMBLED PARTS, ETC.). IN ADDITION, THERE ARE INCOMING AND IN PROCESS INSPECTIONS PERFORMED DURING THE MANUFACTURING OF COMPONENTS AND FINISHED GOOD ITEMS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. ADDITIONALLY, ALL COMPONENTS FROM THE RETAIN SAMPLE FOR THE REPORTED LOT NUMBER WERE VISUALLY INSPECTED FOR ANY CONTAMINATION. THERE WERE NO PIECES OF WIRE, OR ANY PARTICULATES SEEN IN THE SYRINGE OR ANY OTHER COMPONENT OF THE TRAY. A ONE-YEAR HISTORICAL SEARCH WAS COMPLETED ON THE REPORTED 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.

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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: DURING AN EPIDURAL, THE ATTENDING ANESTHESIOLOGIST NOTICED A METAL WIRE INSIDE THE 3 ML SYRINGE. THE DRUG WAS DRAWN UP INTO THE SYRINGE, BUT IT WAS NOT ADMINISTERED TO THE PATIENT.