BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALCOHOL SWABS

    MDR report key: 17452510 · Received August 3, 2023

    Report

    Report Number
    1920898-2023-00509
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. DUE TO THIS BATCH BEING MADE IN 2014 AND FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED. 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.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ALCOHOL SWABS HAD NO EXPIRATION DATE ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VOICE MESSAGE QUESTION DO THE SWAB EXPIRE. CALLED THIS CONSUMER BACK. CALLER ENDED THE CALL WITHOUT CONVERSATION. POSSIBLE THE BOX SHE HAS DOES NOT CONTAIN THE EXPERATION DATE INFORMATION. OUTGOING CALL BACK TO THIS CONSUMER. CALLER STATED FOUND A BOX IN HER HOME. STORED IN HOME FOR QUITE SOMETIME AND NOT USED. WONDERING IF THEY EXPIRE. SHE IS DISPOSING OF THIS BOX.."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ALCOHOL SWABS HAD NO EXPIRATION DATE ON THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VOICE MESSAGE QUESTION DO THE SWAB EXPIRE. CALLED THIS CONSUMER BACK. CALLER ENDED THE CALL WITHOUT CONVERSATION. POSSIBLE THE BOX SHE HAS DOES NOT CONTAIN THE EXPERATION DATE INFORMATION. OUTGOING CALL BACK TO THIS CONSUMER. CALLER STATED FOUND A BOX IN HER HOME. STORED IN HOME FOR QUITE SOMETIME AND NOT USED. WONDERING IF THEY EXPIRE. SHE IS DISPOSING OF THIS BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337860 BD¿ ALCOHOL SWABS PAD, ALCOHOL, DEVICE DISINFECTANT LKB BD MEDICAL - DIABETES CARE 0334008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD¿ ALCOHOL SWABS.