BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE ASSIST PEN NEEDLE

    MDR report key: 17950165 · Received October 17, 2023

    Report

    Report Number
    9616656-2023-01113
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 9, 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

    H.3. 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

    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 10TH 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PACKAGE OF THE BD SAFE ASSIST PEN NEEDLE'S PRODUCT INFORMATION WAS INCORRECT. THE FOLLOWING WAS TRANSLATED FROM GERMAN TO ENGLISH: THE PZN 15320176 (BD SAFEASSIST 5 MM) IS PRINTED ON THE PACKAGING INSTEAD OF 15320182 (BD SAFEASSIST 8 MM). BARCODE IS CORRECT (FOR BD SAFEASSIST 8 MM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PACKAGE OF THE BD SAFE ASSIST PEN NEEDLE'S PRODUCT INFORMATION WAS INCORRECT. THE FOLLOWING WAS TRANSLATED FROM GERMAN TO ENGLISH: THE PZN 15320176 (BD SAFEASSIST 5 MM) IS PRINTED ON THE PACKAGING INSTEAD OF 15320182 (BD SAFEASSIST 8 MM). BARCODE IS CORRECT (FOR BD SAFEASSIST 8 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738286 BD SAFE ASSIST PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown