BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15140849 · Received August 1, 2022

    Report

    Report Number
    2647876-2022-00171
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). 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

    H6: INVESTIGATION SUMMARY: CATALOG: 442020. BATCH NO.: 2070255. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS POSSIBLE CONTAMINATION ON 5 BOTTLES. THE CUSTOMER NOTICED A TREND AND RESULTS DIDN¿T FIT CLINICALLY. ERRONEOUS RESULTS WERE REPORTED TO DOCTORS BUT TREATMENT IS UNKNOWN. THERE WAS NO ADVERSE IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: POSSIBLE CONTAMINATION. CUSTOMER EMAILED THAT BACILLUS CEREUS WAS ISOLATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS POSSIBLE CONTAMINATION ON 5 BOTTLES. THE CUSTOMER NOTICED A TREND AND RESULTS DIDN'T FIT CLINICALLY. ERRONEOUS RESULTS WERE REPORTED TO DOCTORS BUT TREATMENT IS UNKNOWN. THERE WAS NO ADVERSE IMPACT TO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: POSSIBLE CONTAMINATION. CUSTOMER EMAILED THAT BACILLUS CEREUS WAS ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2923649 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442020 2070255 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown