BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALCOHOL SWABS

    MDR report key: 15127334 · Received July 29, 2022

    Report

    Report Number
    1920898-2022-00493
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 28, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 7092504 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(4) WAS USED AS A PLACE HOLDER. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD¿ ALCOHOL SWABS, THE EXPIRATION DATE WAS MISSING FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS NO EXPIRATION DATE ON THE BOX OR SWAB PACKAGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655077 BD¿ ALCOHOL SWABS PAD, ALCOHOL, DEVICE DISINFECTANT LKB BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown