BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 11121797 · Received January 6, 2021

    Report

    Report Number
    1920898-2021-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 5, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC SYRINGE. CUSTOMER STATES THAT THE SYRINGES WOULD NOT DRAW UP INSULIN. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS THEN WIRED AND A WIRE WAS NOT ABLE TO PASS THROUGH THE CANNULA, INDICATING THAT THERE IS AN ADHESIVE CLOG IN THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200884826, 200884828] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE WOULD NOT ASPIRATE THE INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 SYRINGES THAT WOULD NOT DRAW UP INSULIN. JUST GOT A LARGE AIR POCKET. LONG TIME INJECTOR. DOES NOT REUSE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE WOULD NOT ASPIRATE THE INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 SYRINGES THAT WOULD NOT DRAW UP INSULIN. JUST GOT A LARGE AIR POCKET. LONG TIME INJECTOR. DOES NOT REUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19541 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0083507 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1