BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13079247 · Received December 23, 2021

    Report

    Report Number
    1920898-2021-01337
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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# 8113511. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    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 12 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED SYRINGES WITH UNKNOWN CLEAR LIQUID IN SYRINGE BARREL PRIOR TO USE."

    Description of Event or Problem · 0

    IT WAS REPORTED 12 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED SYRINGES WITH UNKNOWN CLEAR LIQUID IN SYRINGE BARREL PRIOR TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975631 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown