BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31X5 ITALY 100 PACK

    MDR report key: 8433552 · Received March 19, 2019

    Report

    Report Number
    9616656-2019-00257
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 24, 2019
    Report Date
    April 25, 2019
    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
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPENED 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 8241517, CAT. NO. 320595. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. NO ISSUES WERE OBSERVED WITH THE PATIENT END OF THE CANNULA. 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. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NEEDLE 31X5 ITALY 100 PACK WAS BENT AND DID NOT ALLOW INSULIN FLOW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT REFERS THAT PNS ARE BENT AND DO NOT ALLOW INJECTION."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NEEDLE 31X5 ITALY 100 PACK WAS BENT AND DID NOT ALLOW INSULIN FLOW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT REFERS THAT PNS ARE BENT AND DO NOT ALLOW INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227999 PEN NEEDLE 31X5 ITALY 100 PACK PEN NEEDLE FMI BECTON DICKINSON AND CO. 8241517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other