BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 16640340 · Received March 29, 2023

    Report

    Report Number
    9616656-2023-00290
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 13, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SIXTY-SIX SEALED 30G X 5MM AUTOSHIELD DUO SAMPLES WERE RETURNED FROM LOT. NO. 2040949, CAT. NO. 329605. VISUAL EXAMINATION OF THIRTY SAMPLES WAS CARRIED OUT AND NO ISSUES WERE 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 NON-PATIENT END OF THE BD AUTOSHIELD¿ DUO PEN NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "ONCE AGAIN THIS PATIENT HAS A COMPLAINT ABOUT THE SAFETY NEEDLES STICKING. THE ISSUE IS WITH A DIFFERENT PACKAGING. THE HOME CARE AGENCY IS EXPERIENCING THIS MORE OFTEN AND EVEN REPORTS TO TAKE THIS INTO CONSIDERATION... AS FAR AS I KNOW, NO INJURY WAS SUSTAINED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD AUTOSHIELD¿ DUO PEN NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "ONCE AGAIN THIS PATIENT HAS A COMPLAINT ABOUT THE SAFETY NEEDLES STICKING. THE ISSUE IS WITH A DIFFERENT PACKAGING. THE HOME CARE AGENCY IS EXPERIENCING THIS MORE OFTEN AND EVEN REPORTS TO TAKE THIS INTO CONSIDERATION... AS FAR AS I KNOW, NO INJURY WAS SUSTAINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176506 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown