BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14197796 · Received April 25, 2022

    Report

    Report Number
    1920898-2022-00284
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 5, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2020067, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 20-JAN-2022, MEDICAL DEVICE LOT #: 1284111, MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2026, DEVICE MANUFACTURE DATE: 11-OCT-2021. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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# 1284111. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB OF BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE SEPARATED AND STAYED INSIDE OF THE SHIELD. THIS ISSUE INVOLVED MULTIPLE LOT NUMBERS; HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. THE ISSUES INVOLVE 2 BOXES OF THE SAME PRODUCT WITH TWO DIFFERENT LOT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB OF BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE SEPARATED AND STAYED INSIDE OF THE SHIELD. THIS ISSUE INVOLVED MULTIPLE LOT NUMBERS; HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD. THE ISSUES INVOLVE 2 BOXES OF THE SAME PRODUCT WITH TWO DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133830 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown