BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9500252 · Received December 20, 2019

    Report

    Report Number
    1920898-2019-01450
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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# 9063703. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE DEVICE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS THAT BY UNCAPPING THE NEEDLE, THE NEEDLE IS RELEASED FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE DEVICE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS THAT BY UNCAPPING THE NEEDLE, THE NEEDLE IS RELEASED FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302466 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 9063703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other