BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 11362104 · Received February 22, 2021

    Report

    Report Number
    1920898-2021-00199
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM HALF UNIT 10BAGSLA HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING THE SYRINGE IN THE AMPOULE BOTTLE AND ASPIRATING THE INSULIN, THE NEEDLE DETACHED ITSELF FROM THE BODY OF THE SYRINGE (TOGETHER WITH THE PLASTIC PART) AND GOT STUCK IN THE RUBBER OF THE BOTTLE. CUSTOMER MENTIONED THAT SHE HAD DIFFICULTY REMOVING THE PROTECTIVE CAP FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING THE SYRINGE IN THE AMPOULE BOTTLE AND ASPIRATING THE INSULIN, THE NEEDLE DETACHED ITSELF FROM THE BODY OF THE SYRINGE (TOGETHER WITH THE PLASTIC PART) AND GOT STUCK IN THE RUBBER OF THE BOTTLE. CUSTOMER MENTIONED THAT SHE HAD DIFFICULTY REMOVING THE PROTECTIVE CAP FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256355 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SYRINGE FMF BD MEDICAL - DIABETES CARE 0020542

    Patients

    Seq Age Sex Outcome Treatment
    1