BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 9292848 · Received November 7, 2019

    Report

    Report Number
    9616656-2019-01088
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 23, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9022892, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-22, MEDICAL DEVICE LOT #: 8282508, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2018-12-06. INVESTIGATION SUMMARY: LEVEL B 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 3RD RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9022892 & THE 4TH RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 8282508. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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 THESE PACKAGED LOTS 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 HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLE 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 2 BOXES OF PEN NEEDLES WERE NOT USABLE. NOTHING COMES OUT OF PEN NEEDLE DURING PRIMING. VERBATIM: ISSUE: NOTHING COMES OUT DURING THE PRIMING, SAMPLE DISCARDED. BOX DISCARDED, SHE USES THE NANO NEEDLE. 1ST BOX ALMOST HALF OF THE BOX: INCIDENT DATE: UNKNOWN, OCCURENCE" UNKNOWN, LOT#: 9022892. 2ND BOX: INCIDENT DATE: UNKNOWN, OCCURENCE: UNKNOWN, LOT#8282508 QUARTER OF THE BOX. CONSUMER USES NEW NEEDLE FOR HER INJECTION SHE VISUALLY SEES IF IT IS STRAIGHT YES. SHE ROTATES THE INJECTION SITE. SHE SOMETIME TIGHTENS THE NEEDLE ON TO THE PEN AND SOMETIMES FIRMLY ATTACHES BUT DOES NOT SEE ANY DIFFERENCE. COMMENTS: I HAVE HAD 2 BOXES OF THE BD NANO ULTRA-FINE PEN NEEDLES THAT WERE NON USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083281 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other