BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALCOHOL SWABS

    MDR report key: 9919179 · Received April 2, 2020

    Report

    Report Number
    1920898-2020-00337
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 25, 2020
    Report Date
    March 30, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #4171558. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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 THE BD¿ ALCOHOL SWAB DID NOT HAVE AN EXPIRATION DATE ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM A CONSUMER. DO THESE SWABS HAVE AN EXPIRATION DATE .? HOW WILL I KNOW IF THEY ARE STILL EFFECTIVE ?THEY ARE SEALED PACKETS. I HAVE HAD THEM FOR AT LEAST 2 YEARS." "NO EXPIRATION DATE. DO THEY EXPIRE?".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382577 BD¿ ALCOHOL SWABS ALCOHOL SWAB LKB BD MEDICAL - DIABETES CARE 4171558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other