BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8133382 · Received December 5, 2018

    Report

    Report Number
    3002682307-2018-00291
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. BD HAS BEEN PROVIDED ALSO WITH THE AFFECTED SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THREE OF THESE PROVIDED SAMPLES. AFTER THAT BD DETERMINED A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. BD COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW FOR LOT # 1802178: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2011 (FEBRUARY 11TH - 12TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #8036714 (FEBRUARY 6TH ¿ 12TH, 2018), AND IN LOT #8043944 (FEBRUARY 12TH ¿ 19TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8037759, #8008857, #8043965, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8037765, #8030581, #8043964 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER THAT BD DETERMINED A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. BD COULD CONFIRM THE REPORTED ISSUE. DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS VERY LOW AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ SYRINGE WITH NEEDLE HAD LEAKAGE AT THE INNER BARREL.

    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 THAT A BD¿ SYRINGE WITH NEEDLE HAD LEAKAGE AT THE INNER BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973353 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1802178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other