BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8504185 · Received April 11, 2019

    Report

    Report Number
    9616656-2019-00337
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 26, 2019
    Report Date
    March 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 THERE WAS NO INSULIN FLOW THROUGH THE BD ULTRA FINE¿ PEN NEEDLE DURING THE INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED DURING INJECTION, NO INSULIN FLOW. HE PROVIDED TWO LOT NUMBERS AND DESCRIPTION OF PEN NEEDLES USED. USING A NANO PEN NEEDLE AND MINI PEN NEEDLE. LOT: 7101669 FOR NANO, LOT: 5161322 FOR MINI PEN NEEDLES. STATED HE WAS READING INFORMATION FROM ACTUAL PEN NEEDLE. BOXES DISCARDED. STATED HE AND HIS SON ARE DIABETICS AND THEY ARE SHARING PEN NEEDLES. CONSUMER NOT SURE WHICH PEN NEEDLE HAD THE ISSUE, MINI OR NANO. STATED USES A FLEX PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298003 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 7101669 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other