BD FLUSH SYRINGE

Additional Manufacturer Narrative

D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. 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 FLUSH SYRINGE HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 DURING ROUTINE INTRAVENOUS INFUSION AND PICC CATHETER FLUSHING FOR A PATIENT, A SMALL DEFECT WAS DISCOVERED AT THE LOWER END OF THE CATHETER. USE WAS IMMEDIATELY DISCONTINUED, AND A NEW PRE-FILLED CATHETER FLUSHING SET WAS USED TO COMPLETE THE TREATMENT. DEFECTIVE LOWER END OF PREFILLED CATHETER FLUSHER.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP. AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.