BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12832423 · Received November 17, 2021

    Report

    Report Number
    2647876-2021-00287
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED BLOOD UNDER THE SENSOR, FALSE POSITIVE AND CONTAMINATION ISSUES. FIVE PHOTOS WERE RECEIVED WITH SENSOR ADHESION DEFECT. 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. BLOOD BACKGROUND WAS PERFORMED WITH SATISFACTORY RESULTS. RETENTION SAMPLES WERE ALSO TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. 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. SENSOR ADHESION SCRAPE TEST IS PERFORMED TO EACH SENSOR BATCH AS PART OF RELEASE CRITERIA. COMPLAINT IS CONFIRMED FOR SENSOR ADHESION DEFECT BASED ON PHOTOS RECEIVED. 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 THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) EXPERIENCED 2 CASES OF PHYSICAL DEFECT, 1 CASE OF FALSE POSITIVE TEST RESULTS, AND 1 CASE OF BIOLOGICAL CONTAMINATION. CONFIRMATORY GRAM TESTING WAS PERFORMED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTTLES ARE LOADED IN BIOCHEMISTRY AS OUR MACHINES ARE REMOTE TO THE DEPARTMENT. THE MACHINE IMMEDIATELY WENT BARMY, WHEN IT FIRST MEASURED THE SAMPLE THE FLUORESCENCE MUST HAVE BEEN OFF THE SCALE, THIS SUGGESTS TO ME THAT THE SEEPAGE OCCURRED BEFORE THE BOTTLE WAS LOADED. I CANNOT SAY AS TO HOW THE BOTTLE WAS DELIVERED TO THE DEPARTMENT THERE ARE TWO METHODS, POD SYSTEM AND PORTER. IT CAUSED A SYSTEM ALERT BUT ALSO FLAGGED THE BOTTLE AS POSITIVE. BOTTLE WAS SUBBED NO ORGANISMS WERE SEEN IN THE GRAM, THE BOTTLE WAS RELOADED TO WHERE IT IMMEDIATELY CAUSED SYSTEM ALERT ERROR 09. ON REMOVING THE VIAL THE STAFF THEN NOTICED THE BLOOD SAMPLE HAD SEEPED BELOW THE SENSOR PAD, WE THEN INCUBATED THE BOTTLE IN THE INCUBATOR FOR THE DURATION AND WAS SUBSEQUENTLY POSITIVE GROWING A ROSEOMONAS MUCOSA AT DAY 3 ON DAILY SUB, WHICH WAS OF UNCERTAIN SIGNIFICANCE AS THIS WAS THE ONLY ISOLATE AND THE PATIENT WAS CLINICALLY WELL. NO OTHER SETS WERE TAKEN. BLOOD HAS LEAKED UNDER THE SENSOR AT THE BASE OF THE VIAL. CUSTOMER SAYS IT HAS OCCURRED WITH TWO VIALS DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) EXPERIENCED 2 CASES OF PHYSICAL DEFECT, 1 CASE OF FALSE POSITIVE TEST RESULTS, AND 1 CASE OF BIOLOGICAL CONTAMINATION. CONFIRMATORY GRAM TESTING WAS PERFORMED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTTLES ARE LOADED IN BIOCHEMISTRY AS OUR MACHINES ARE REMOTE TO THE DEPARTMENT. THE MACHINE IMMEDIATELY WENT BARMY, WHEN IT FIRST MEASURED THE SAMPLE THE FLUORESCENCE MUST HAVE BEEN OFF THE SCALE, THIS SUGGESTS TO ME THAT THE SEEPAGE OCCURRED BEFORE THE BOTTLE WAS LOADED. I CANNOT SAY AS TO HOW THE BOTTLE WAS DELIVERED TO THE DEPARTMENT THERE ARE TWO METHODS, POD SYSTEM AND PORTER. IT CAUSED A SYSTEM ALERT BUT ALSO FLAGGED THE BOTTLE AS POSITIVE. BOTTLE WAS SUBBED NO ORGANISMS WERE SEEN IN THE GRAM, THE BOTTLE WAS RELOADED TO WHERE IT IMMEDIATELY CAUSED SYSTEM ALERT ERROR 09. ON REMOVING THE VIAL THE STAFF THEN NOTICED THE BLOOD SAMPLE HAD SEEPED BELOW THE SENSOR PAD, WE THEN INCUBATED THE BOTTLE IN THE INCUBATOR FOR THE DURATION AND WAS SUBSEQUENTLY POSITIVE GROWING A ROSEOMONAS MUCOSA AT DAY 3 ON DAILY SUB, WHICH WAS OF UNCERTAIN SIGNIFICANCE AS THIS WAS THE ONLY ISOLATE AND THE PATIENT WAS CLINICALLY WELL. NO OTHER SETS WERE TAKEN. BLOOD HAS LEAKED UNDER THE SENSOR AT THE BASE OF THE VIAL. CUSTOMER SAYS IT HAS OCCURRED WITH TWO VIALS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726367 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1124154 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown