BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8126299 · Received December 3, 2018

    Report

    Report Number
    3002682307-2018-00289
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 20, 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 THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE PROVIDED SAMPLE. AFTER THAT BD DETERMINED A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. WE COULD CONFIRM THE REPORTED ISSUE. DHR REVIEW ON LOT 1803185: WE HAVE 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 (MARCH 16TH - 17TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4251, Nº4252, IN LOT #8067504 (MARCH 12TH ¿ 23RD, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8067999, AND #8050847, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8075991, #8072883, AND #8065749, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER THE EVALUATION OF THE RECEIVED SAMPLE, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD WAS PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE 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 REALLY 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 THE BD¿ SYRINGE WITH NEEDLE LEAKED AT THE PLUNGER ROD.

    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 THE BD¿ SYRINGE WITH NEEDLE LEAKED AT THE PLUNGER ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963081 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1803185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other