BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAB ALCOHOL

    MDR report key: 9936523 · Received April 8, 2020

    Report

    Report Number
    1920898-2020-00354
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SWABS DRY AND EXPIRED PRODUCT ON LOT #4B100. INVESTIGATION SUMMARY: NO SAMPLES 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. AS PER MANUFACTURING: DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 4B100 WAS MANUFACTURED ON FEBRUARY 2004 (16 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: 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 3 SWABS ALCOHOL EXPERIENCED PRODUCT USE BEYOND SHELF LIFE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 326895 BATCH NO. 4B100. VERBATIM: CONSUMER REPORTED -THE FIRST 3 SWABS OPENED WHERE DRY. CLAIMS TO JUST PURCHASED THIS BOX. DATE OF EVENT: (B)(6) 2020. SHE REFUSES TO GO OUT OF THE HOUSE. ONLY HAS A COMMUNITY MAIL BOX FOR RECEIVING AND SENDING DOWN THE STREET. NO MAIL CARRIER AT THE DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400421 SWAB ALCOHOL ALCOHOL SWAB LKB BD MEDICAL - DIABETES CARE 4B100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other