BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV

    MDR report key: 7571139 · Received June 5, 2018

    Report

    Report Number
    1920898-2018-00407
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 2, 2018
    Report Date
    June 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294610
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1/2CC SYRINGE. CUSTOMER STATES THAT THERE WAS AN ANOMALY IN THE SYRINGE. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED A BOWED/DAMAGED BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121544. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSE: MOLDING PROCESSING ISSUE (PARTS WERE BLOCKED AND ASSOCIATE DIDN'T BACK OFF THE PLASTIC INFEED, WATER PROBLEMS, OVERPACKING, ETC.). MATERIAL HANDLING (DURATION OF COMPONENTS BEING STORED IN TOTES).

    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 BARREL ON A BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV WAS FOUND BOWED/CRACKED PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410451 BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7121544 30382903294610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other