BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8496260 · Received April 9, 2019

    Report

    Report Number
    9616656-2019-00328
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 22, 2019
    Report Date
    March 27, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8247890; MEDICAL DEVICE EXPIRATION DATE: 2023-08-31; DEVICE MANUFACTURE DATE: 2018-09-04; MEDICAL DEVICE LOT #: 8171657; MEDICAL DEVICE EXPIRATION DATE: 2023-07-31; DEVICE MANUFACTURE DATE: 2018-08-29; MEDICAL DEVICE LOT #: 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. 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUES ARE UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A NEEDLE CLOG OCCURRED WITH A BD ULTRA FINE¿ PEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO. 320122, BATCH NO. 8247890, 8171657, UNKNOWN. IT WAS REPORTED THAT NEEDLES ARE CLOGGED AND NEEDLE IS BENT AT NON PATIENT END. VERBATIM: CONSUMER REPORTED NEEDLE CLOG AND NEEDLE BENT AT NON PATIENT END OF HUB DURING INJECTION, ALSO STATED THAT THE NEEDLES DO NOT WORK DURING PRIMING. CONSUMER IS NEW TO USING PEN NEEDLES, STARTED ABOUT FIVE MONTHS AGO, PROBLEM OCCURRED WITH EVERY BOX SINCE. I REVIEWED THE STEPS FOR ATTACHING PEN NEEDLES. CONSUMER PROVIDED TWO LOT #S 8247890, EXP 08-31-23 AND LOT # 8171657, EXP 07-31-23, PRODUCT # 320122. SAMPLES WERE DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287721 BD ULTRA FINE¿ PEN NEEDLES PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other