BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22733646 · Received August 6, 2025

    Report

    Report Number
    3006948883-2025-00366
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 10, 2025
    Report Date
    November 24, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1: INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 THAT WHEN THE DOCTOR INSERTED THE COLLECTION SWAB INTO THE PATIENT'S THROAT, THE COTTON TIP CAME OFF. THERE WERE AN ADDITIONAL 5 COLLECTION SWABS IN WHICH THE COTTON TIP CAME OFF. 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. THERE WERE NO RETURN SAMPLES RECEIVED AT THE TIME OF COMPLAINT CLOSURE; HOWEVER, IF SAMPLES ARE RECEIVED AT A LATER DATE, THIS COMPLAINT MAY BE REOPENED. HOWEVER, THERE WERE PHOTOS RECEIVED FROM THE CUSTOMER. BASED ON THE RETURNED PHOTOS, ONLY THE KIT LABEL, THE LOT NUMBER OF THE SAMPLING SWAB, AND THE APPEARANCE OF THE KIT AFTER OPENING ARE VISIBLE. A TREND ANALYSIS FOR BROKEN SWAB WAS CONDUCTED, AND 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.

    Description of Event or Problem · 0

    REPORT 4 OF 6. 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 FELL OFF INTO A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THERE WAS NO ADVERSE IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 4 OF 6. 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 FELL OFF INTO A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THERE WAS NO ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725651 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