BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12586382 · Received October 6, 2021

    Report

    Report Number
    2647876-2021-00155
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    July 24, 2021
    Report Date
    October 11, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC. RETENTION 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 SAMPLES AND BATCH HISTORY RECORD REVIEW. 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. 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. 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 WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING BACTEC BOTTLES 442021, LOT 1132326, HAVE COME POSITIVE FOR PAENIBACILLUS SP. THE CUSTOMER HAS HAD BOTTLES FROM DIFFERENT PATIENTS THAT HAVE COME POSITIVE FOR PAENIBACLLUS SP. THE CUSTOMER STATES THEY DID SEE THE ORGANISM ON THE GRAM STAIN. IT STAINS GRAM VARIABLE, SOMETIMES MORE GRAM POSITIVE AND SOMETIMES MORE GRAM NEGATIVE. TWO BOTTLES HAVE BEEN CONFIRMED SO FAR AND ONE HAS BEEN SENT OUT BUT CUSTOMER BELIEVES WILL COME BACK POSITIVE FOR THE ORGANISM. CUSTOMER SENDS OUT POSITIVE CULTURES TO THE STATE FOR ID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING BACTEC BOTTLES 442021, LOT 1132326, HAVE COME POSITIVE FOR PAENIBACILLUS SP. THE CUSTOMER HAS HAD BOTTLES FROM DIFFERENT PATIENTS THAT HAVE COME POSITIVE FOR PAENIBACLLUS SP. THE CUSTOMER STATES THEY DID SEE THE ORGANISM ON THE GRAM STAIN. IT STAINS GRAM VARIABLE, SOMETIMES MORE GRAM POSITIVE AND SOMETIMES MORE GRAM NEGATIVE. TWO BOTTLES HAVE BEEN CONFIRMED SO FAR AND ONE HAS BEEN SENT OUT BUT CUSTOMER BELIEVES WILL COME BACK POSITIVE FOR THE ORGANISM. CUSTOMER SENDS OUT POSITIVE CULTURES TO THE STATE FOR ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481907 BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 1132326 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1