BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN

    MDR report key: 23368673 · Received October 23, 2025

    Report

    Report Number
    3006948883-2025-00792
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    UDI-DI
    00382902560579
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES SAFETY (BROKEN SWAB) WHEN USING KIT VERITOR SYSTEM STREP A 10 TESTS JP (MATERIAL#: 256057), BATCH NUMBER: 4220796. THE CUSTOMER REPORTED DURING SAMPLE COLLECTION, THE COTTON TIP OF THE COLLECTION SWAB FELL OFF INSIDE THE PATIENT'S MOUTH. THEY CONFIRMED THAT THE PATIENT WAS NOT INJURED. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. A TREND ANALYSIS FOR BROKEN SWAB WAS CONDUCTED; A TREND WAS IDENTIFIED. A SUPPLIER CORRECTIVE ACTION WAS OPENED WITH THE SUPPLIER, AND THE REPORTED ISSUE IS CONFIRMED. THE SUPPLIER WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE ISSUE; HOWEVER, THEY HAVE IMPLEMENTED PROCESSES TO REDUCE THE RISK OF TIP DETACHMENT.

    Additional Manufacturer Narrative · 0

    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 WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN, THE COTTON SWAB FROM THE TIP OF ONE (1) APPLICATOR WAS REMOVED FROM A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THERE WAS NO ADVERSE IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN, THE COTTON SWAB FROM THE TIP OF ONE (1) APPLICATOR WAS REMOVED FROM A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THERE WAS NO ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545779 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4220796 00382902560579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown