BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11175759 · Received January 15, 2021

    Report

    Report Number
    1920898-2021-00064
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 24, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9091562. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200815571] NOTED FOR OUT OF SPEC BREAKOUT AND SUSTAINING.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLUNGER ROD WOULD NOT PULL DOWN WHEN PLACING AIR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PLUNGER ROD WOULD NOT PULL DOWN WHEN PLACING AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74492 BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9091562

    Patients

    Seq Age Sex Outcome Treatment
    1