BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15188784 · Received August 8, 2022

    Report

    Report Number
    2647876-2022-00182
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 22, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 2122794. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. 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 RESULTS. 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.

    Description of Event or Problem · 0

    T WAS REPORTED BY THE CUSTOMER THAT 7 BACTEC VIALS TURNED POSITIVE FOR BACILLUS CEREUS IN ONE DAY. FOUR DIFFERENT LOT NUMBERS, FOUR DIFFERENT PATIENTS, TWO DIFFERENT WARD STATIONS. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC).REPEAT TESTING WAS PERFORMED. NO PATIENT IMPACT WAS REPORTED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 7 BACTEC VIALS TURNED POSITIVE FOR BACILLUS CEREUS IN ONE DAY FOUR DIFFERENT LOT NUMBERS, FOUR DIFFERENT PATIENTS, TWO DIFFERENT WARD STATIONS. WERE THE VIALS MANUALLY SUBCULTURED AND GRAM STAINED? YES. IF YES, WHAT WAS THE RESULT? BACILLUS CEREUS SPP. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 7 BACTEC VIALS TURNED POSITIVE FOR BACILLUS CEREUS IN ONE DAY. FOUR DIFFERENT LOT NUMBERS, FOUR DIFFERENT PATIENTS, TWO DIFFERENT WARD STATIONS. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC).REPEAT TESTING WAS PERFORMED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 7 BACTEC VIALS TURNED POSITIVE FOR BACILLUS CEREUS IN ONE DAY FOUR DIFFERENT LOT NUMBERS, FOUR DIFFERENT PATIENTS, TWO DIFFERENT WARD STATIONS. WERE THE VIALS MANUALLY SUBCULTURED AND GRAM STAINED? YES. IF YES, WHAT WAS THE RESULT? BACILLUS CEREUS SPP. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287482 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 2122794 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown