BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 7196412 · Received January 16, 2018

    Report

    Report Number
    3002682307-2017-00157
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 25, 2017
    Report Date
    February 12, 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: SAMPLE EVALUATION- WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. THE EVALUATION OF THE RETURNED SAMPLE SHOWED A HAIR INSIDE THE BLISTER OF THE SYRINGE. WE COULD CONFIRM THE REPORTED ISSUE. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2011. SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7100073 (APRIL 18 - 29TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7100035, AND #7089485 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7114316, #7100040, AND #7089486 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS THE ACCURATE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. BASED ON THE EVALUATION OF THE SAMPLE WE THINK THAT THE HAIR WAS LOST PROBABLY DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, OR NEGLECT, OR AS PART OF SOME RAW MATERIALS. FINALLY THIS FOREIGN MATTER ENDED IN THE PRIMARY PACKAGING MACHINE WHICH PRODUCED THE MENTIONED NON-CONFORMANCE. WE CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE. CONFIRMATION THE RETURNED SAMPLE PRESENTED A HAIR INSIDE THE UNIT PACKAGE OF THE SYRINGE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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 NURSE OPENED THE BD SYRINGE WITH NEEDLE AND FOUND FOREIGN MATTER IN THE SHAPE OF A HAIR INSIDE THE BARREL. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41793 BD SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON, S.A. 1704160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other