BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 16475814 · Received March 2, 2023

    Report

    Report Number
    3008352382-2023-00010
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 31, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 2305651, MEDICAL DEVICE EXPIRATION DATE: 2023-08-31, DEVICE MANUFACTURE DATE: 2022-11-01. INITIAL REPORTER ADDR 1: (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

    H.6 INVESTIGATION SUMMARY: BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION/RETURNED SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION/RETURNED SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. REFER TO CUSTOMER LETTER. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. CATALOG: 442023. BATCH NO.: UNKNOWN. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE LOT NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. OCCURANCE: 8.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS MOLECULAR FALSE POSITVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNKNOWN RECEIVED; LOT # 2305651 (4 BX) AND 2284976 (5 BX). CUSTOMER STATES BACTEC FLAGS POS, CULTURE AND GRAM STAIN POS AND MATCH. BIOFIRE BCID 2 DETECTED CANDIDA TROPICALIS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNKNOWN RECEIVED; LOT # 2305651 (4 BX) AND 2284976 (5 BX) CUSTOMER STATES BACTEC FLAGS POS, CULTURE AND GRAM STAIN POS AND MATCH. BIOFIRE BCID 2 DETECTED CANDIDA TROPICALIS. OCCURENCE: 8 WITH UNKNOWN LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS MOLECULAR FALSE POSITVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNKNOWN RECEIVED; LOT # 2305651 (4 BX) AND 2284976 (5 BX) CUSTOMER STATES BACTEC FLAGS POS, CULTURE AND GRAM STAIN POS AND MATCH. BIOFIRE BCID 2 DETECTED CANDIDA TROPICALIS. OCCURANCE: 8 WITH UNKNOWN LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058690 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown