BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE

    MDR report key: 6956190 · Received October 17, 2017

    Report

    Report Number
    1911916-2017-00274
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 28, 2017
    Report Date
    March 1, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903053118
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NO PHOTOS OR SAMPLES WERE RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. DHR: 305311-5142547 CONVERSION TO 8000585 BATCHES 4203842, 4307507, AND 4273665. ALL BATCHES WERE REVISED AND NO DEFECTS WERE FOUND IN DHR'S. BASED ON THE ABOVE, CAPA NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE WAS FOUND LEAKING DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734112 BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142547 30382903053118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other