BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    MDR report key: 10565207 · Received September 22, 2020

    Report

    Report Number
    9616656-2020-00940
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 10, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.3. DATE OF EVENT: (B)(6) 2020 THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.4. DATE RECEIVED BY MANUFACTURER: 2020-09-10.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 3 NOVEMBER 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329515 BATCH NO: 9141969 EVENT DESCRIPTION PER MEDWATCH REPORT STATES: NEEDLE FOR INSULIN PEN WOULD NOT EXPEL MEDICATION OR AIR. WHEN NEEDLE WAS REMOVED FROM THE PEN, IT WAS FOUND THAT THE "INTERNAL" NEEDLE WAS BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329515 BATCH NO: 9141969 EVENT DESCRIPTION PER MEDWATCH REPORT STATES: NEEDLE FOR INSULIN PEN WOULD NOT EXPEL MEDICATION OR AIR. WHEN NEEDLE WAS REMOVED FROM THE PEN, IT WAS FOUND THAT THE "INTERNAL" NEEDLE WAS BENT.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 13 JULY, 2020. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329515 BATCH NO: 9141969. EVENT DESCRIPTION PER MEDWATCH REPORT STATES: NEEDLE FOR INSULIN PEN WOULD NOT EXPEL MEDICATION OR AIR. WHEN NEEDLE WAS REMOVED FROM THE PEN, IT WAS FOUND THAT THE "INTERNAL" NEEDLE WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035598 PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 9141969 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other