BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12650023 · Received October 18, 2021

    Report

    Report Number
    1119779-2021-01671
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 21, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904413866
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE WITH BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY GRAM AND SUBCULTURE WERE PERFORMED AND NO ORGANISMS WERE DETECTED. THERE WAS NO PATIENT IMPACT. D.1. MEDICAL DEVICE BRAND NAME: BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC). D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON CARIBE LTD ¿ CAYEY, PR / (B)(4). D.4 MEDICAL DEVICE CATALOG #: 442021; D.4. MEDICAL DEVICE LOT #: 1153220; D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1 MANUFACTURING LOCATION: BECTON DICKINSON CARIBE LTD ¿ CAYEY, PR / (B)(4). G.5. PMA / 510(K)#: K123903; H.4. DEVICE MANUFACTURE DATE: 2021-06-02.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/1/2021. H.6. INVESTIGATION: CUSTOMER REPORTED A FALSE POSITIVE DEFECT. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION AND RETURNED GOOD SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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. USERS ARE CAUTIONED IN THE PACKAGE INSERT UNDER LIMITATION OF THE PROCEDURE: ¿A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBER OF NON-VIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDE AND SPECIMENS USED FOR INOCULATION. THERE ARE MANY FACTORS THAT CAN INFLUENCE THE FALSE POSITIVE RATE, INCLUDING BLOOD VOLUME, BLOOD CELL COUNTS, ENVIRONMENTAL FACTORS, AND MEDIA LOT TO LOT VARIATIONS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION AND RETURNED GOOD SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. NO CORRECTIVES 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 INVESTIGATION PROCESS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE WITH BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY GRAM AND SUBCULTURE WERE PERFORMED AND NO ORGANISMS WERE DETECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DRAWER D FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE WITH BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY GRAM AND SUBCULTURE WERE PERFORMED AND NO ORGANISMS WERE DETECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DRAWER D FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE IN BD BACTEC¿ FX, INSTRUMENT BOTTOM, PACKAGED A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY GRAM AND SUBCULTURE WERE PERFORMED AND NO ORGANISMS WERE DETECTED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DRAWER D FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548157 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 441386 1153220 00382904413866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown