BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES

    MDR report key: 8495622 · Received April 9, 2019

    Report

    Report Number
    9616657-2019-00177
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) 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 CONFORMANCES 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 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 DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES THERE WAS A CLOG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122, BATCH NO: 8150783. IT WAS REPORTED: THAT THE CONSUMER ENCOUNTERED THAT NOTHING COMES OUT OF THE PEN NEEDLE WHEN SHE INJECTS ON THE SKIN. PRIMING YES. NOTHING COMES OUT ON SOME NEEDLES. VERBATIM: CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE WHEN SHE INJECTS ON THE SKIN. PRIMING YES. NOTHING COMES OUT ON SOME NEEDLES. SAMPLE DISCARDED. SHE USES NEW NEEDLES EACH TIME. INCIDENT DATE; UNKNOWN; LOT- 8150783; EXPIRATION DATE- 01/30/2023; ITEM# 320122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287462 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8150783

    Patients

    Seq Age Sex Outcome Treatment
    1 Other