BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL

    MDR report key: 11825381 · Received May 14, 2021

    Report

    Report Number
    3003152976-2021-00265
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    March 3, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL? YES. D10. RETURNED TO MANUFACTURER ON: (B)(6) 2021. INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, ALTHOUGH THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD, IT WAS FOUND THERE WAS DAMAGE TO THE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT 2010100, NO DEVIATIONS OR NON CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS, HOWEVER, A DAILY INCIDENT REPORT DID IDENTIFY THERE WERE JAMMED PIECES WITHIN THE ASSEMBLY MACHINE. ONCE DETECTED, THE MECHANICAL TEAM REPAIRED THE FAILURE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB PROCESSES ACCORDING TO PROCEDURES, INCLUDING LEAKAGE TESTING TO VERIFY THE STOPPER SEAL. THE RETURNED SAMPLE UNDERWENT THESE SAME TESTS AND AGAIN A LEAKAGE WAS OBSERVED. BASED ON THE QUALITY TEAM'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO THE JAM THAT OCCURRED DURING MANUFACTURING, THE BARREL BECOMING DAMAGED AND CAUSING THE LEAK WHEN THE STOPPER IS MOVED ACROSS THE DAMAGE PORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 50ML LL LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PISTON SEAL IS PERMEABLE (BODY/PISTON INTERFACE) SIGNIFICANT LEAKAGE WHEN USING THE PISTON COULD HAVE PREVENTED PROPER ADMINISTRATION OF RESUSCITATION TREATMENTS. INFORMATION GIVEN TO THE NURSES.

    Additional Manufacturer Narrative · 1

    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 WHILE USING BD SYRINGE 50ML LL LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PISTON SEAL IS PERMEABLE (BODY/PISTON INTERFACE) SIGNIFICANT LEAKAGE WHEN USING THE PISTON COULD HAVE PREVENTED PROPER ADMINISTRATION OF RESUSCITATION TREATMENTS. INFORMATION GIVEN TO THE NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723850 BD SYRINGE 50ML LL PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010100

    Patients

    Seq Age Sex Outcome Treatment
    1