BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 12833286 · Received November 17, 2021

    Report

    Report Number
    1920898-2021-01206
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/19/2021. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE 0.5ML SYRINGE. FUNCTIONALITY TESTING WAS PERFORMED ON THE SYRINGE BY ATTEMPTING TO DRAW WATER. IT WAS NOTED THAT DESPITE AMPLE TIME PROVIDED, SYRINGE COULD ONLY DRAW A MINIMAL AMOUNT OF WATER. POTENTIAL BLOCKAGE OF THE SYRINGE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1172330. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. NO ROOT CAUSE DETERMINED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WOULD NOT ASPIRATE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BEING UNABLE TO DRAW MEDICATION INTO SYRINGE. CONSUMER STATED MULTIPLE SYRINGES AFFECTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WOULD NOT ASPIRATE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED BEING UNABLE TO DRAW MEDICATION INTO SYRINGE. CONSUMER STATED MULTIPLE SYRINGES AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723976 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 1172330 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown