BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15306672 · Received August 26, 2022

    Report

    Report Number
    9616656-2022-00916
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    July 21, 2022
    Report Date
    September 24, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2040952. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. H4: DEVICE MANUFACTURE DATE: 2022-02-09. D4: MEDICAL DEVICE LOT #: 2074945. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-03-15. H4: DEVICE MANUFACTURE DATE: 2025-04-30. D4: MEDICAL DEVICE LOT #: 1099885. D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 12-SEP-2022. 407 SEALED 30G X 5MM SAFETY PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2040952, ALONG WITH 89 SEALED SAMPLES FROM LOT. NO. 2074945 AND FIVE SEALED SAMPLES FROM LOT. NO. 1099885, CAT. NO. 329605. VISUAL EXAMINATION WAS CARRIED OUT ON ALL RETURNED SAMPLES AND NO ISSUES WERE OBSERVED. AN ACTIVATION TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THIRTY SAMPLES FROM LOT. NO. 2040952, THIRTY SAMPLES FROM LOT. NO, 2074945 AND FIVE SAMPLES FROM LOT. NO. 1099885 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS 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.

    Description of Event or Problem · 0

    THIS MDR ADDRESSES PATIENT 1 OF 2. IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PEN NEEDLE WAS BEING USED ON HOSPITAL WARD. PEN WAS BELIEVED TO BE NOT PROPERLY PRIMED AND PEN NEEDLES IN THE BOX WERE BENT AT THE CARTRIDGE END OF THE PEN NEEDLE. THEREFORE INSULIN DOSE WAS NOT ADMINISTERED TO TWO PATIENTS ON THE WARD.

    Description of Event or Problem · 0

    THIS MDR ADDRESSES PATIENT 1 OF 2. IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PEN NEEDLE WAS BEING USED ON HOSPITAL WARD. PEN WAS BELIEVED TO BE NOT PROPERLY PRIMED AND PEN NEEDLES IN THE BOX WERE BENT AT THE CARTRIDGE END OF THE PEN NEEDLE. THEREFORE INSULIN DOSE WAS NOT ADMINISTERED TO TWO PATIENTS ON THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200945 BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2040952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown