BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL BNS

    MDR report key: 8496313 · Received April 9, 2019

    Report

    Report Number
    1213809-2019-00420
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 21, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010271
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 5ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE HAD AN INSECURE STOPPER CONDITION AND IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. WHEN THE STOPPERS ARE ATTACHED TO THE PLUNGER RODS, THEY ARE GRABBED ONE AT A TIME USING A DIAL. IF THE DIAL BECOME WORN THE PLACEMENT WILL BE SLIGHTLY OFF CAUSING IT TO NOT BE SEATED PROPERLY. THIS CAN ALSO HAPPEN IF THE TIMING IS OFF BETWEEN THE PLUNGER ROD DIAL AND THE STOPPER DIAL. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEFORMED STOPPER FOR A SYRINGE 5ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, " WE HAVE A COMPLAINT FOR ONE OF YOUR SYRINGES. COMPLAINT DESCRIPTION: OUR CUSTOMER REPORTED THE FOLLOWING ISSUE: LOCKED DUE TO SKEWED RUBBER MEMBRANE. CAN YOU PLEASE INVESTIGATE THIS COMPLAINT: "REVIEW" OF THE BATCH RELATED DOCUMENTATION OF THIS LOT: WERE THERE REMARKS DURING MANUFACTURING? DID THIS LOT MEET THE SPECIFICATIONS? WERE ANY ITEMS REJECTED DURING MANUFACTURING BECAUSE OF THE OBSERVED ISSUE? DO YOU HAVE PREVENTIVE MEASURES? "ROOT" CAUSE AND CORRECTIVE ACTIONS? "WHICH" CONTROL CHECKS DO YOU PERFORM TO CHECK THE INTEGRITY? FOLLOWING LOTS WERE IN USE: 8182732. I WOULD LIKE TO KNOW WHAT THE CAUSE IS OF THIS DEFECT AND WHAT THE CORRECTIVE ACTION WILL BE TO PREVENT THIS FROM HAPPENING IN THE FUTURE. I WOULD LIKE TO KNOW IF WE CAN BE SURE THAT WE WILL RECEIVE THE GOOD QUALITY IN THE FUTURE. COMPLAINT SAMPLE SHOULD AT LEAST BE KEPT FOR 5 YEARS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DEFORMED STOPPER FOR A SYRINGE 5ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, " WE HAVE A COMPLAINT FOR ONE OF YOUR SYRINGES. COMPLAINT DESCRIPTION: OUR CUSTOMER REPORTED THE FOLLOWING ISSUE: LOCKED DUE TO SKEWED RUBBER MEMBRANE. CAN YOU PLEASE INVESTIGATE THIS COMPLAINT: REVIEW OF THE BATCH RELATED DOCUMENTATION OF THIS LOT: WERE THERE REMARKS DURING MANUFACTURING? DID THIS LOT MEET THE SPECIFICATIONS? WERE ANY ITEMS REJECTED DURING MANUFACTURING BECAUSE OF THE OBSERVED ISSUE? DO YOU HAVE PREVENTIVE MEASURES? ROOT CAUSE AND CORRECTIVE ACTIONS? WHICH CONTROL CHECKS DO YOU PERFORM TO CHECK THE INTEGRITY? FOLLOWING LOTS WERE IN USE: 8182732 . I WOULD LIKE TO KNOW WHAT THE CAUSE IS OF THIS DEFECT AND WHAT THE CORRECTIVE ACTION WILL BE TO PREVENT THIS FROM HAPPENING IN THE FUTURE. I WOULD LIKE TO KNOW IF WE CAN BE SURE THAT WE WILL RECEIVE THE GOOD QUALITY IN THE FUTURE. COMPLAINT SAMPLE SHOULD AT LEAST BE KEPT FOR 5 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287628 SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8182732 00382903010271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other