BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO

    MDR report key: 15415525 · Received September 14, 2022

    Report

    Report Number
    9616656-2022-00983
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 14, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1134005 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024 H.4. DEVICE MANUFACTURE DATE: 14-MAY-2021 H.6 INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD DUO IS TO EASY TO DISCHARGE BEFORE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINIC NURSES STATED THAT IT IS TOO EASY TO DISCHARGE THE SAFETY FEATURE BEFORE THE INJECTION IS GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD DUO IS TO EASY TO DISCHARGE BEFORE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINIC NURSES STATED THAT IT IS TOO EASY TO DISCHARGE THE SAFETY FEATURE BEFORE THE INJECTION IS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784957 BD AUTOSHIELD DUO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1134005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown