BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2" BD ULTRA-FINE¿ NEEDLE

    MDR report key: 6730530 · Received July 20, 2017

    Report

    Report Number
    1920898-2017-00093
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 30, 2017
    Report Date
    August 7, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 5162602 FOR NEEDLE BREAKS OFF DURING USE. THIS IS THE 4TH. RELATED COMPLAINT FOR NEEDLE BREAKS OFF IN USE ON LOT # 5162602.. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN NEEDLES WERE COMING OFF OF THE BARREL AND SOME BREAKING OFF ON THE 1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2" BD ULTRA-FINE¿ NEEDLE DURING USE. NO INJURY OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508313 1ML BD SAFETY-LOK¿ U-100 INSULIN SYRINGE WITH 29 G X 1/2" BD ULTRA-FINE¿ NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 5162602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other