BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 9843725 · Received March 17, 2020

    Report

    Report Number
    9616656-2020-00238
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 20, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    NSC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (1) OPEN 4MM, 32G PEN NEEDLE FROM LOT # 9141570. CUSTOMER STATES THAT THE NEEDLE CLOGGED DURING PRIMING AND NEEDLE WAS BENT AT NON PATIENT END BEFORE INJECTION. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN NON PATIENT END OF THE CANNULA). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. 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. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144, BATCH NO. 9141570. IT WAS REPORTED THAT NEEDLE CLOGGED DURING PRIMING AND NEEDLE WAS BENT AT NON PATIENT END BEFORE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, AND NEEDLE BENT AT NON PATIENT END BEFORE INJECTION. DOES NOT RE-USE.

    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 BD ULTRA-FINE¿ PEN NEEDLE CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144 BATCH NO. 9141570. IT WAS REPORTED THAT NEEDLE CLOGGED DURING PRIMING AND NEEDLE WAS BENT AT NON PATIENT END BEFORE INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, AND NEEDLE BENT AT NON PATIENT END BEFORE INJECTION. DOES NOT RE-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309215 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE NSC BECTON DICKINSON AND CO. 9141570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other