BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO SAFETY PEN NEEDLE

    MDR report key: 15505609 · Received September 29, 2022

    Report

    Report Number
    9616656-2022-01058
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 7, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 11-OCT-2022. H6: INVESTIGATION SUMMARY: ONE SEALED 30G X 5MM SAFETY PEN NEEDLE SAMPLE AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 2040002, CAT. NO. 329705. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND BURN MARKS ON THE COVER 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. BURN MARKS OCCURRED DUE TO THE MOULDING PRESS STOPPING WHILST HEATS REMAINED ON THE INJECTION UNIT.

    Additional Manufacturer Narrative · 0

    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 AUTOSHIELD DUO SAFETY PEN NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE DISTRIBUTOR'S REPORT IS THAT BLACK SPOT WAS FOUND ONTO THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD DUO SAFETY PEN NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE DISTRIBUTOR'S REPORT IS THAT BLACK SPOT WAS FOUND ONTO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2935101 BD AUTOSHIELD DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown