BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT

    MDR report key: 17946858 · Received October 16, 2023

    Report

    Report Number
    3006948883-2023-00108
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 22, 2023
    Report Date
    November 5, 2023
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560425
    PMA / PMN Number
    K133140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT INVOLVED KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042, BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED MISSING LABELS WITH RSV KIT, AND THEY COULD NOT PROVIDE THE LOT NUMBER. WHILE INQUIRING, THEY CLARIFIED THAT THE KIT CONTENTS CAME WITHOUT A BOX, SO THEY WERE UNABLE TO DETERMINE THE LOT # OF THE KIT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE LABELING / PACKAGING ISSUE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING COULD NOT BE PERFORMED BECAUSE A BATCH NUMBER WAS NOT PROVIDED. NO PHYSICAL SAMPLES WERE RETURNED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE CONDUCTED. HOWEVER, THE CUSTOMER PROVIDED THE PHOTOGRAPHS, WHICH SHOWED RSV KIT CONTENTS WERE PACKED IN A PLASTIC COVER WITHOUT BOX. THIS COMPLAINT WAS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR LABELING / PACKAGING ISSUE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT, THERE WERE MISSING LABELS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT LABELS ARE MISSING AND THEY ARE UNABLE TO DETERMINE LOT #S CUSTOMER CLARIFIED THAT THE ISSUE IS THAT THE PLASTIC BAG IN THE PHOTO IS KIT CONTENTS THAT CAME WITHOUT A BOX, SO THEY ARE UNABLE TO DETERMINE THE LOT # OF THE KIT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT, THERE WERE MISSING LABELS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT LABELS ARE MISSING AND THEY ARE UNABLE TO DETERMINE LOT #S CUSTOMER CLARIFIED THAT THE ISSUE IS THAT THE PLASTIC BAG IN THE PHOTO IS KIT CONTENTS THAT CAME WITHOUT A BOX, SO THEY ARE UNABLE TO DETERMINE THE LOT # OF THE KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336052 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown