BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8485248 · Received April 4, 2019

    Report

    Report Number
    9616656-2019-00312
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A 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 1ST RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 8143543. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 31G, 5MM BD PEN NEEDLES WITHOUT THE TEAR DROP LABELS ATTACHED (USED). CONSUMER REPORTED THAT NOTHING CAME OUT DURING THE PEN NEEDLE. THE RETURNED PEN NEEDLES WERE EXAMINED AND TESTED FOR FLOW. ALL (4) TESTED PEN NEEDLES PASSED THE FLOW TEST (NO CLOGS OBSERVED), THEREFORE THE ALLEGED DEFECT COULD NOT BE CONFIRMED. 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. 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 WERE 5 OCCURRENCES WHERE INSULIN WAS UNABLE TO BE DELIVERED WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT NOTHING CAME OUT DURING THE PEN NEEDLE. SHE HAS SAMPLES TO SEND BACK. LOT# 8143543; EXPIRATION DATE-2023-05-31; ITEM# 320199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274934 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8143543 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other