BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 8165708 · Received December 14, 2018

    Report

    Report Number
    1920898-2018-00940
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 28, 2018
    Report Date
    December 10, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY: CUSTOMER RETURNED (20) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT THE BARRELS APPEAR LARGER AND THE SYRINGES WILL NOT DRAW MEDICATION. ALL RETURNED SYRINGES WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON ANY OF THE SAMPLES. ALL SAMPLES WERE ALSO TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8120618. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD A BARREL THAT APPEARED LARGER THAN SEEN IN THE PAST. SOME SYRINGES DID NOT DRAW MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003184 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8120618 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other