BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM

    MDR report key: 15547039 · Received October 5, 2022

    Report

    Report Number
    1920898-2022-00688
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DEVICE EVALUATED BY MFR IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    D4: MEDICAL DEVICE LOT #: 2010796. D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. H4: DEVICE MANUFACTURE DATE: 10-JAN-2022. H6: 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# 2010796. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM IT WAS REPORTED BY THE CONSUMER THAT NEEDLE BROKE OFF, CAUSED BLEEDING, AND ALSO 3 NEEDLES WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED FOR TWENTY YEARS ON AND OFF, NEEDLES HAVE BROKEN OFF IN HIS SKIN WHEN TAKING INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM IT WAS REPORTED BY THE CONSUMER THAT NEEDLE BROKE OFF, CAUSED BLEEDING, AND ALSO 3 NEEDLES WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED FOR TWENTY YEARS ON AND OFF, NEEDLES HAVE BROKEN OFF IN HIS SKIN WHEN TAKING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337529 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM HYPODERMIC SINGLE LUMEN NEEDLE FMF BD MEDICAL - DIABETES CARE 328468 2010796 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown