BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ IV INSULIN SYRINGE

    MDR report key: 7370950 · Received March 26, 2018

    Report

    Report Number
    1920898-2018-00163
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 12, 2018
    Report Date
    May 1, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    30382903294245
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED 100 1CC, 12.7MM, 28G INSULIN SYRINGES IN SEALED BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 7072881. CUSTOMER STATES THAT THE NEEDLE IS BARBED, CAUSING DAMAGE TO THE VEINS, CAUSING ABSCESSES, AND THE PLUNGER IS VERY STIFF. THIRTY OUT OF 100 RETURNED SYRINGES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 28G: 0.0140¿-0.0145¿). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. ALL OF THESE SAMPLES WERE ALSO TESTED AND THE PLUNGER RODS WERE ABLE TO MOVE WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7072881. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE ON A BD MICRO-FINE¿ IV INSULIN SYRINGE WAS BARBED, CAUSING DAMAGE TO VEINS AND THERE WERE A FEW PEOPLE WHO DEVELOPED ABSCESSES AFTER INJECTION. IT WAS ALSO REPORTED THAT THE PLUNGER ON THE SYRINGE WAS STIFF AND DIFFICULT TO MOVE. THERE WAS NO REPORT OF MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214900 BD MICRO-FINE¿ IV INSULIN SYRINGE INSULIN SYRINGE FMI BD MEDICAL - DIABETES CARE 7072881 30382903294245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other