BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 8285731 · Received January 29, 2019

    Report

    Report Number
    3002682307-2019-00111
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 13, 2019
    Report Date
    March 28, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 1802192: 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 PACKAGED IN MACHINE Nº2028 (FEBRUARY 12TH ¿ 13TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8029659 (JANUARY 29TH ¿ FEBRUARY 5TH, 2018), LOT #8036712 (FEBRUARY 5TH ¿ 12TH, 2018) AND LOT #8043942 (FEBRUARY 12TH ¿ 19TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8043958, #8037757, #8022719, #8015780, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8043963, #8037764, #8030580, #8022723, #8015644, #7354665, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. VISUAL INSPECTION OF THE PICTURE PRESENTED THE TOP OF THE BARREL BROKEN. THAT CONFIRMED THE REPORTED ISSUE. CONCLUSION(S): AFTER ANALYZING THE RETURNED PICTURE OF THE SAMPLE AND DISCUSSING WITH OUR MANUFACTURING TECHNICIANS IN CHARGE OF THESE PRODUCT LINES, BD HAVE CONCLUDED THAT THE BROKEN BARREL WAS PRODUCED IN THE PRIMARY PACKAGING MACHINE, IN THE SYRINGE FEEDER STATION, DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGE PRODUCED THE RUPTURE OF THE BARREL. THE BARREL WAS BROKEN DURING THE MANUFACTURING PROCESS DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGES IN THE FEEDER OF THE PRIMARY PACKAGING MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH THE BARREL WAS FOUND BROKEN AFTER OPENING THE UNIT PACKAGE.

    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 WITH THE USE OF THE BD SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH THE BARREL WAS FOUND BROKEN AFTER OPENING THE UNIT PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79068 BD SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1802192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other