BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15686156 · Received October 27, 2022

    Report

    Report Number
    1920898-2022-00751
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282784
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER E-MAIL: UNKNOWN. 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

    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# 1201648. 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 3 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAD LOOSE SHIELDS AND EXPOSED NEEDLES INSIDE THEIR SEALED PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THREE SYRINGES HAD EXPOSED NEEDLES, STATED THAT THE SHIELDS WERE LOOSE INSIDE OF THE SEALED BAG.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAD LOOSE SHIELDS AND EXPOSED NEEDLES INSIDE THEIR SEALED PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THREE SYRINGES HAD EXPOSED NEEDLES, STATED THAT THE SHIELDS WERE LOOSE INSIDE OF THE SEALED BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725188 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328278 1201648 00382903282784

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown