BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES

    MDR report key: 8484849 · Received April 4, 2019

    Report

    Report Number
    2243072-2019-00655
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 20, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 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. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER FOR NEEDLE CLOG. 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

    MATERIAL NO.: 320122, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES THE PEN WOULD NOT PRESS THE LIQUID INTO THE CONSUMER'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PEN DID NOT PRESS THE LIQUID IN TO HIS SKIN. HE SEES SMALL DROP OF INSULIN STAYS IN HIS NEEDLE PEN DURING HE INJECTS THE PEN TO HIS SKIN. HE HAD 10-12 PENS WITH THE SAME ISSUE. SAMPLE DISCARDED. HE DOES THE PRIMING. LOT # 8150783; EXPIRATION DATE- 2023-2-30; ITEM# 320122; INCIDENT DATE- (B)(6) 2019. HE USES NEW PEN NEEDLE EACH TIME OF HIS INJECTION. THIS HAS HAPPEN IN THE PAST, NO SAMPLE, LOT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274553 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other