BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFEASSIST¿ SAFETY PEN NEEDLE

    MDR report key: 17283577 · Received July 7, 2023

    Report

    Report Number
    9616656-2023-00707
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A CAPA WAS RAISED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.3. 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 THAT PRIOR TO USE WITH 4000 BD SAFEASSIST¿ SAFETY PEN NEEDLE THE PZN NUMBER ON THE PRODUCT IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CLAIMED WRONG PZN PRINTED ON THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 4000 BD SAFEASSIST¿ SAFETY PEN NEEDLE THE PZN NUMBER ON THE PRODUCT IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CLAIMED WRONG PZN PRINTED ON THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677899 BD SAFEASSIST¿ SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown