BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 20326886 · Received September 27, 2024

    Report

    Report Number
    1119779-2024-00706
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    July 16, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902518273
    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

    IN THIS MDR, BD SITE IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS (B)(4) JP IS A REPACKAGING SITE FOR THE JAPANESE MARKET ONLY. 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

    INVESTIGATION SUMMARY: THE COMPLAINT IS FOR MATERIAL NUMBER: 251827, BATCH NUMBER: 3269157 FOR FALSE RESISTANCE ISSUE. THIS PRODUCT IS REPACKAGED IN JAPAN FROM MATERIAL NUMBER: 245128 TO 251827 WITH THE SAME BATCH NUMBER OF 3269157. THE MANUFACTURER PERFORMED THE INVESTIGATION. NO BATCH HISTORY ANOMALY AND NO RETENTION SAMPLE ANOMALY. TWO PHOTOS WERE RECEIVED. BOTH PHOTOS SHOW A PRINTOUT OF TESTING RESULTS. NO CONCLUSIONS ABOUT TESTING CAN BE MADE FROM THE TEST RESULTS SHARED. BASED ON THE INVESTIGATION, THE CAUSE WAS UNDETERMINED SINCE THERE IS NO RECORD ANOMALY. HOWEVER, THERE IS A COMPLAINT TREND FOR 245128 MGIT PZA KIT FOR PERFORMANCE. BASED ON THE TREND FOR 245128 IN PERFORMANCE COMPLAINTS, THE COMPONENT FOR THIS KIT, BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) FOR FURTHER INVESTIGATION. THE COMPLAINT IS CONFIRMED BASED ON THE COMPLAINT TREND IDENTIFIED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT THERE WAS A SUSPECTED FALSE RESISTANCE TO PZA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT THERE WAS A SUSPECTED FALSE RESISTANCE TO PZA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434190 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 3269157 00382902518273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown