BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO¿ PEN NEEDLE

    MDR report key: 17380199 · Received July 24, 2023

    Report

    Report Number
    9616656-2023-00764
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 26, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6) INVESTIGATION SUMMARY: ONE PHOTO OF AN OPEN 30G X 5MM AUTOSHIELD DUO SAMPLE, A LOOSE SPRING AND AN INSULIN PEN WERE RETURNED. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS CARRIED OUT AND A BENT PIECE OF CANNULA WAS OBSERVED IN THE SEPTUM OF THE PEN. AS NO PHYSICAL SAMPLES WERE RETURNED, NO FURTHER INVESTIGATION CAN BE CARRIED OUT. BASED ON THE PHOTO RETURNED IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 26-SEP-2023. INVESTIGATION SUMMARY: ONE 30G X 5MM AUTOSHIELD DUO SPRING AND SHIELD WERE RETURNED FROM LOT NO. 2221513, CAT. NO. 329505 ALONG WITH ONE PHOTO. VISUAL EXAMINATION ON THE RETURNED SAMPLE WAS CARRIED OUT AND NO CANNULA WAS OBSERVED. VISUAL EXAMINATION OF THE RETURNED PHOTO WAS ALSO CARRIED OUT AND A BROKEN PIECE OF CANNULA WAS OBSERVED IN THE SEPTUM OF THE PEN. BASED ON THE PHOTO AND THE FACT THE SAMPLE WAS RETURNED OPENED, IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    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 AUTOSHIELD DUO¿ PEN NEEDLE THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INNER NEEDLE DISINTEGRATION AFTER INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD DUO¿ PEN NEEDLE THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INNER NEEDLE DISINTEGRATION AFTER INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD DUO¿ PEN NEEDLE THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INNER NEEDLE DISINTEGRATION AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423350 BD AUTOSHIELD DUO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2221513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown