BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 9608248 · Received January 20, 2020

    Report

    Report Number
    9616656-2020-00022
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 16, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9162522. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 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: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9162522. IT WAS REPORTED THAT INSULIN IS NOT FLOWING DURING PRIMING AND INJECTION. VERBATIM: ISSUE: NURSE EDUCATOR CALLED ON BEHALF OF A CONSUMER TO REPORT INSULIN IS NOT FLOWING, NEEDLE DOES NOT DISPENSES THE INSULIN DURING THE PRIMING AND SOMETIMES DURING THE INJECTION, IT ONLY PARTIALLY DISPENSES THE MEDICINE. IT HAS HAPPENED WITH HALF OF THE TIMES. CONSUMER USES NEW NEEDLE EACH TIME OF HIS INJECTION, HE VISUALLY TESTS THE NEEDLE TO SEE IF IT IS STRAIGHT ON BOTH END. HE DOES THE PRIMING AND HE FIRMLY ATTACHES THE NEEDLE STRAIGHT ON TO THE PEN. SPOKE TO THE CONSUMER WHO WAS AT THE DOCTORS OFFICE, UPDATED HIS INFORMATION. ADVISED CONSUMER TO SAVE THE SAMPLE IF RE OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72015 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2865 9162522 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other