BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 7727072 · Received July 27, 2018

    Report

    Report Number
    3002682307-2018-00187
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    July 5, 2018
    Report Date
    August 23, 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

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER, DEVICE SINGLE USE?: NO, DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH A PICTURE AND THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, WE CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS CONGLOMERATE PARTICLES OF SLIP AGENT FROM THE INJECTION PROCESS IN THE TIP. DHR FOR LOT NUMBER 1610129: 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 Nº2020 (OCTOBER 4TH ¿ 5TH, 2016). NEEDLES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4220, Nº4210, IN LOT #6274300 (SEPTEMBER 30TH ¿ OCTOBER 6TH, 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6273145, #6270156, #6264119, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6273151, #6270161, #6264123, #6253445, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. DURING THE INJECTION PROCESS THERE IS A PHASE OF GAS EXPULSION, IN THIS CASE, THE MOLD PIECE IN CHARGE OF THIS FUNCTION DID NOT WORK AS EXPECTED AND THIS AMOUNT OF SLIP AGENT PARTICLES FINALLY END INSIDE THE BARREL, THE BARREL TIP WAS NOT CORRECTLY FORMED. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS SINCE REVIEW OF THE 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 FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD¿ SYRINGE WITH NEEDLE BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD¿ SYRINGE WITH NEEDLE BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567951 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1610129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other