BD SYRINGE 5ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

(B)(4) FOLLOW UP FOR DEVICE EVALUATION. A WHITE FOREIGN MATTER WAS REPORTED IN TWO FLUSHES. TO SUPPORT THE INVESTIGATION, ONE EMPTY SAMPLE WITHOUT PACKAGING, FLOW WRAP, OR TIP CAP, ALONG WITH FIVE PHOTOGRAPHS, WAS PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED, DURING WHICH THE SYRINGE PLUNGER ROD, RUBBER STOPPER, AND SYRINGE BARREL LABEL WERE REMOVED. THE RUBBER STOPPER SHOWED RESIDUES OF LUBRICANT, AND THE SYRINGE BARREL EXHIBITED RUB MARKS. THE FIVE PHOTOGRAPHS CORRESPONDED TO THE SAMPLE RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE LUBRICANT USED DURING MANUFACTURING IS MEDICAL GRADE AND APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND THE RUBBER STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 306594, LOT 5073468, REVEALED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER¿S REPORTED SYMPTOM HAS BEEN CONFIRMED.

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FILL CHINA SP HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO USE, WHITE FOREIGN MATTER WAS DISCOVERED IN TWO BOTTLES OF FLUSH. DEFECTIVE PRODUCTS MAY BE RETURNED. PHOTOGRAPHIC EVIDENCE IS AVAILABLE. NO CLAIM IS REQUIRED. A COMPLAINT RESPONSE LETTER IS REQUESTED. NO COMPLAINT RECEIPT LETTER IS NEEDED. A PRODUCT EXCHANGE IS REQUIRED. THE DETAILED PICTURE IS AS FOLLOWS, THE DEPARTMENT FOUND THAT THERE WERE 2 FOREIGN BODY PRODUCTS IN THE TUBE WHEN USING, LOT CODE: 5073468, THE HEAD NURSE SUSPENDED ALL BD PRECHARGING AFTER DISCOVERING, AND AFTER FULL COMMUNICATION AND EXPLANATION, IT WAS TEMPORARILY AGREED TO REPLACE THE NEW BATCH OF PRE-CHARGING AND USE, AND REQUIRED THAT THIS BATCH OF PRODUCTS NO LONGER BE USED. RETURNS HAVE BEEN MADE. NOW APPLY FOR THE RETURN OF THIS BATCH WITH THE COMPANY, A TOTAL OF 6 BOXES FLUSH, AND FINALLY ISSUE AN EXPLANATION REPORT TO THE HOSPITAL, THANK YOU.