BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT)

    MDR report key: 16861461 · Received May 3, 2023

    Report

    Report Number
    9616656-2023-00432
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE DEVICE WAS DIFFICULT TO OPERATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED BD AUTOSHIELD DUO PEN NEEDLES AND THEY DID NOT INCLUDE WRITTEN INSTRUCTIONS. THERE ARE PICTURES INSTRUCTIONS, BUT THE CUSTOMER INDICATES THEY ARE DIFFICULT TO USE. THE CUSTOMER FEELS THAT THE DEVICE ITSELF IS OVERLY COMPLICATED TO USE. NO ADVERSE EVENTS OR SERIOUS INJURIES REPORTED. THE CUSTOMER IS SEEKING A CREDIT. ITEM # 329515. LOT # 2221527. EVENT DATE (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE DEVICE WAS DIFFICULT TO OPPERATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED BD AUTOSHIELD DUO PEN NEEDLES AND THEY DID NOT INCLUDE WRITTEN INSTRUCTIONS. THERE ARE PICTURES INSTRUCTIONS, BUT THE CUSTOMER INDICATES THEY ARE DIFFICULT TO USE. THE CUSTOMER FEELS THAT THE DEVICE ITSELF IS OVERLY COMPLICATED TO USE. NO ADVERSE EVENTS OR SERIOUS INJURIES REPORTED. THE CUSTOMER IS SEEKING A CREDIT. ITEM # 329515, LOT # 2221527, EVENT DATE 04/11/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532966 BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 2221527 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown