BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE IV INSULIN SYRINGE

    MDR report key: 8401471 · Received March 7, 2019

    Report

    Report Number
    1920898-2019-00232
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    January 28, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294207
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED PHOTOS OF A 1ML SYRINGE. CUSTOMER STATES THAT THE NEEDLES BREAK OR "CROOKS" WHEN INJECTING INTO THE SKIN OR WHEN RECAPPING THE NEEDLE. THE ATTACHED PHOTOS WERE EXAMINED AND NO BENT OR BROKEN CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121840. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THAT THE NEEDLES BREAK OR "CROOKS" WHEN INJECTING INTO THE SKIN OR WHEN RECAPPING THE NEEDLE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7240669; MEDICAL DEVICE EXPIRATION DATE: 2022-10-31; DEVICE MANUFACTURE DATE: 2017-08-28. MEDICAL DEVICE LOT #: 7121840; MEDICAL DEVICE EXPIRATION DATE: 2022-05-31; DEVICE MANUFACTURE DATE: 2017-05-01. 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 DURING USE OF THE BD MICRO-FINE¿ IV INSULIN SYRINGE THAT THE NEEDLES BREAK OR "CROOKS" WHEN INJECTING INTO THE SKIN OR WHEN RECAPPING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194259 BD MICRO-FINE IV INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 30382903294207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other