BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31G 5MM 5B XTW 105BX DE

    MDR report key: 9770682 · Received February 28, 2020

    Report

    Report Number
    9616656-2020-00170
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THIRTY FIVE SEALED AND INTACT 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9071883, CAT. NO. 320522. A CLOG TEST WAS CARRIED OUT ON ALL THIRTY FIVE SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. INVESTIGATION CONCLUSION A CLOG TEST WAS CARRIED OUT ON ALL THIRTY FIVE SAMPLES AS PER TP700483 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE DESCRIPTION NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. RATIONALE BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 31G 5MM 5B XTW 105BX DE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT PERMEABLE NEEDLES."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT PN 31G 5MM 5B XTW 105BX DE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT PERMEABLE NEEDLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235736 PN 31G 5MM 5B XTW 105BX DE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9071883

    Patients

    Seq Age Sex Outcome Treatment
    1 Other