BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17260912 · Received July 5, 2023

    Report

    Report Number
    9616656-2023-00691
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 6, 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 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. 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 THAT PRIOR TO USE WITH 2 BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL HAD THE INCORRECT INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED ABOUT THE WRONG PZN ON THE PRODUCT. REKG000965262. DELIVERY BILL NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 2 BD SAFEASSIST¿ SAFETY PEN NEEDLE 30G X 5MM (100 COUNT) THE LABEL HAD THE INCORRECT INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINED ABOUT THE WRONG PZN ON THE PRODUCT. REKG000965262. DELIVERY BILL NO: 604571.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418015 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