BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR

    MDR report key: 16209274 · Received January 19, 2023

    Report

    Report Number
    1119779-2023-00045
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTO
    UDI-DI
    00382902317272
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO NO GROWTH FOR TAXO V FACTORS CATALOG 231727 BATCH NO.: 6924935 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR DURING VALIDATION NO GROWTH OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO GROWTH OF HAEMOPHILUS INFLUENZAE AT THE EDGE OF 60 DISC WITH THE USE OF A COS + FACTOR V MEDIUM DURING VALIDATION NO GROWTH , ARE TESTING NOW WITH OTHER BATCH , TOMORROW NOON 11/1/2023 12H I HAVE TO CALL THE CUSTOMER FOR RESULTS OTHER BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR DURING VALIDATION NO GROWTH OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO GROWTH OF HAEMOPHILUS INFLUENZAE AT THE EDGE OF 60 DISC WITH THE USE OF A COS + FACTOR V MEDIUM DURING VALIDATION NO GROWTH , ARE TESTING NOW WITH OTHER BATCH , TOMORROW NOON 11/1/23 12H I HAVE TO CALL THE CUSTOMER FOR RESULTS OTHER BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389713 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION JTO BECTON, DICKINSON & CO. (SPARKS) 231727 2056543 00382902317272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown