BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19538202 · Received June 14, 2024

    Report

    Report Number
    2647876-2024-00084
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 3, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CATALOG 442023. BATCH NO. 3263591. 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. 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.

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER FACILITY NAME: (B)(6). G5: PMA/510(K)#: K222591. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER REPORTED POSSIBLE BLOOD CULTURE CONTAMINATION. ONE PATIENT WAS AFFECTED BY THE FALSE RESULT AND WAS TREATED WITH ANTIFUNGAL MEDICATION IN RESPONSE. ADDITIONALLY, THE CUSTOMER REPORTED THEY BELIEVE THE CONTAMINATION IS NOT THE RESULT OF A PRODUCT ISSUE AND MAY BE ASSOCIATED WITH COLLECTION TECHNIQUE. NO ADVERSE IMPACT REPORTED AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER REPORTED POSSIBLE BLOOD CULTURE CONTAMINATION. ONE PATIENT WAS AFFECTED BY THE FALSE RESULT AND WAS TREATED WITH ANTIFUNGAL MEDICATION IN RESPONSE. ADDITIONALLY, THE CUSTOMER REPORTED THEY BELIEVE THE CONTAMINATION IS NOT THE RESULT OF A PRODUCT ISSUE AND MAY BE ASSOCIATED WITH COLLECTION TECHNIQUE. NO ADVERSE IMPACT REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372737 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3263591 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention