BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12869521 · Received November 24, 2021

    Report

    Report Number
    2647876-2021-00297
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420222
    PMA / PMN Number
    K141810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED SENSOR ADHESION DEFECT AND A FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BATCH/SENSOR 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. BLOOD BACKGROUND WAS PERFORMED SATISFACTORY RESULTS. SENSOR ADHESION SCRAPE TEST IS PERFORMED TO EACH SENSOR BATCH AS PART OF RELEASE CRITERIA. COMPLAINT IS UNCONFIRMED BASED RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. THE VISION SYSTEM IS CHALLENGED PRIOR EACH LOT. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. CAPA#2882676 WAS INITIATED TO FURTHER INVESTIGATE THESE TYPES OF COMPLAINTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 WHILE TESTING WITH BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A GRAM STAIN AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER¿S INFORMATION, 4 TESTS WERE PERFORMED FOR ONE PATIENT YESTERDAY, WITH 2 EACH OF ANAEROBIC AND AEROBIC BOTTLES. WITH ONE ANAEROBIC BOTTLE AMONG THESE, A POSITIVE RESULT WAS SHOWN AFTER 0.8 HOUR. HOWEVER, NO BACTERIA WAS FOUND. THE SAME THING (POSITIVE RESULT, THEN NO BACTERIA FOUND) OCCURRED IN A RE-TEST TODAY. THEN IN ANOTHER TEST A POSITIVE RESULT WAS SHOWN AFTER ONE HOUR, AND IN A DIFFERENT POSITION IT BECAME POSITIVE AFTER ONE HOUR. AS THE CUSTOMER CHECKED THE BOTTOM OF THE BOTTLE, BLOOD WAS FOUND TO HAVE ENTERED THE SENSOR. (B)(6) 2021/PW - CLARIFICATION FROM TASK - ISSUE IS ALL ON ONE ANAEROBIC BOTTLE -THE SAME BOTTLE WAS MOVED MULTIPLE TIMES UNTIL THEY CHECKED THE SENSOR AND SAW THE BLOOD UNDERNEATH THE SENSOR.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING A GRAM STAIN AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER¿S INFORMATION, 4 TESTS WERE PERFORMED FOR ONE PATIENT YESTERDAY, WITH 2 EACH OF ANAEROBIC AND AEROBIC BOTTLES. WITH ONE ANAEROBIC BOTTLE AMONG THESE, A POSITIVE RESULT WAS SHOWN AFTER 0.8 HOUR. HOWEVER, NO BACTERIA WAS FOUND. THE SAME THING (POSITIVE RESULT, THEN NO BACTERIA FOUND) OCCURRED IN A RE-TEST TODAY. THEN IN ANOTHER TEST A POSITIVE RESULT WAS SHOWN AFTER ONE HOUR, AND IN A DIFFERENT POSITION IT BECAME POSITIVE AFTER ONE HOUR. AS THE CUSTOMER CHECKED THE BOTTOM OF THE BOTTLE, BLOOD WAS FOUND TO HAVE ENTERED THE SENSOR. 05NOV2021/(B)(4) - CLARIFICATION FROM TASK - ISSUE IS ALL ON ONE ANAEROBIC BOTTLE -THE SAME BOTTLE WAS MOVED MULTIPLE TIMES UNTIL THEY CHECKED THE SENSOR AND SAW THE BLOOD UNDERNEATH THE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765798 BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442022 1110385 00382904420222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown