BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12507191 · Received September 21, 2021

    Report

    Report Number
    2647876-2021-00080
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 22, 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

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLE SINCE NEITHER BATCH NUMBER NOR RETURNED GOODS SAMPLES WERE AVAILABLE. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. COMPLAINTS FOR CATALOG REPORTED HAVE BEEN RECEIVED. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN AND CULTURE WERE USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, EVEN THOUGH THE ANAEROBIC BOTTLE SHOWED A POSITIVE RESULT, NO BACTERIAL APPEARANCE WAS FOUND IN IT. RIGHT AFTER RELOADING THE BOTTLE, IT SHOWED A POSITIVE RESULT AGAIN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN AND CULTURE WERE USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, EVEN THOUGH THE ANAEROBIC BOTTLE SHOWED A POSITIVE RESULT, NO BACTERIAL APPEARANCE WAS FOUND IN IT. RIGHT AFTER RELOADING THE BOTTLE, IT SHOWED A POSITIVE RESULT AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406052 BD BACTEC PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442022 UNKNOWN 00382904420222

    Patients

    Seq Age Sex Outcome Treatment
    1