BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFEASSIST¿ SAFETY PEN NEEDLE

    MDR report key: 17098943 · Received June 9, 2023

    Report

    Report Number
    9616656-2023-00569
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 16, 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: THREE PHOTOS OF A 30G X 8MM SAFEASSIST CARTON WERE RETURNED FROM LOT. NO. 3010167, CAT. NO. 329917. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND AN INCORRECT PZN CODE WAS OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THIS COMPLAINT WAS CONFIRMED TO BE A PACKAGING GRAPHICS ERROR THEREFORE A REVIEW OF THE PACKAGING PROCESS AT THE SITE IS NOT REQUIRED. ROOT CAUSE WILL BE DETERMINED AS PART OF A CAPA.

    Additional Manufacturer Narrative · 0

    H3. 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 THE BD SAFEASSIST¿ SAFETY PEN NEEDLE PZN NUMBER ON THE PRODUCT IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOWEDA COMPLAINS THAT THE PZN NUMBER ON THE ABOVE PRODUCT IS WRONG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFEASSIST¿ SAFETY PEN NEEDLE PZN NUMBER ON THE PRODUCT IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOWEDA COMPLAINS THAT THE PZN NUMBER ON THE ABOVE PRODUCT IS WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270742 BD SAFEASSIST¿ SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown