BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAB ALCOHOL 100 BX 1200 ASIA

    MDR report key: 8355045 · Received February 20, 2019

    Report

    Report Number
    1920898-2019-00193
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 6, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF BD ALCOHOL SWABS FROM LOT # 8180697. CUSTOMER STATES THAT THE PRODUCT HAS FOREIGN MATTER AND DIRT. THE PHOTOS WERE EXAMINED AND EXHIBITED A SWAB PAD WITH SPLICING TAPE ON THE PAD MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8180697. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR LEAKERS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. POSSIBLE ROOT CAUSE: THERE IS AN ELECTRONIC SENSOR THAT READS THE PAD MATERIAL FOR EXTRA MATERIAL ON THE MACHINE AND MONITORS FOR WHEN A SPLICE COMES THROUGH. UPON DETECTION OF SPLICE TAPE OR ANY OTHER FOREIGN MATTER AFFECTING THE COLOR OF THE PAD MATERIAL, A PROGRAM WITHIN THE MANUFACTURING OPERATION AUTOMATICALLY CYCLES A PREDETERMINED AMOUNT OF SWABS TO BE SENT INTO THE TRASH JUST AFTER STARTUP OF THE MACHINE TO PREVENT THIS DEFECT FROM REACHING THE PACKAGING OPERATION. WHEN A MACHINE JAM OCCURS (STOPPING THE MACHINE) THAT MUST BE MANUALLY ATTENDED TO PAST THE ELECTRONIC EYE, OPERATORS MUST LEAVE A SLIGHT AMOUNT OF SLACK IN THE PAD MATERIAL AROUND A GUIDE ROLLER WHEN THE MACHINE IS RESTARTED TO PREVENT FURTHER JAMMING. THE ELECTRONIC EYE MEASURES THE AMOUNT OF PAD BETWEEN WHERE MATERIAL IT WOULD CATCH TO BE THROWN AWAY AND THE EYE BASED UPON NORMAL MACHINE MATERIAL LOCATIONS. IF THERE IS TOO MUCH SLACK AROUND THE PATH OF THE GUIDE ROLLER UPON MACHINE START UP, THE MACHINE COULD POTENTIALLY CEASE THROWING AWAY SWABS BEFORE THE AFFECTED AREA REACHES THE TRASH AND THEN THE DEFECTIVE SWABS WOULD CONTINUE ON TO PACKAGING. THIS IS WHY OPERATORS ALSO WATCH THE SPLICED MATERIAL PROGRESS THROUGH THE ASSEMBLY PROCEDURE. WITH THE SEVERITY OF THIS DEFECT BEING AN S1 AND THE OCCURRENCE IMPROBABLE, IT CAN BE CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS ERROR AND TO MINIMIZE ITS OCCURRENCE. SPLICE TAPE APPEARS CONSISTENT WITH THAT USED BY BD MEDICAL. THEREFORE, THE ELECTRONIC SENSOR FAILED TO KICK OFF THE AFFECTED SWABS WITH THE SPLICE TAPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SWAB ALCOHOL 100 BX 1200 HAD FOREIGN MATTER AND DIRT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A SWAB ALCOHOL 100 BX 1200 HAD FOREIGN MATTER AND DIRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149446 SWAB ALCOHOL 100 BX 1200 ASIA ALCOHOL SWAB LKB BD MEDICAL - DIABETES CARE 8180697

    Patients

    Seq Age Sex Outcome Treatment
    1 Other