BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT)

    MDR report key: 17421330 · Received July 28, 2023

    Report

    Report Number
    9616656-2023-00792
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 7, 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: TWO PHOTOS OF A 30G X 8MM SAFEASSIST CARTON WAS RETURNED FROM LOT NO. 3010167, CAT. NO. 329917. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS CARRIED OUT AND AN INCORRECT PZN CODE WAS OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NONCONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE 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 CAPA. A CAPA WAS RAISED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL INFORMATION WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GO COMPLAINED THAT THERE IS A WRONG PZN ON THE ABOVE PRODUCT. IN ADDTION, ONLY 6X ITEMS WERE DELIVERED INSTEAD OF 8X.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL INFORMATION WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GO COMPLAINED THAT THERE IS A WRONG PZN ON THE ABOVE PRODUCT. IN ADDITION, ONLY 6X ITEMS WERE DELIVERED INSTEAD OF 8X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327496 BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown