BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14457681 · Received May 20, 2022

    Report

    Report Number
    2647876-2022-00144
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 14, 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY: CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED: IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAD TWO FALSE POSITIVES. GRAM STAIN WAS PERFORMED TO CONFIRM. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 CASE OF FALSE POSITIVE RESULTS USING MEDIA 442021 WITH LOT#: 2040814. ADDITIONAL INFORMATION RECEIVED: (B)(6) : (B)(6) 2022 20:09:41 (GMT) CUSTOMER REPORTS A TOTAL OF 2 VIALS AFFECTED WITH A FALSE POSITIVE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAD ONE FALSE POSITIVE. GRAM STAIN WAS PERFORMED TO CONFIRM. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 CASE OF FALSE POSITIVE RESULTS USING MEDIA 442021 WITH LOT#: 2040814.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAD TWO FALSE POSITIVES. GRAM STAIN WAS PERFORMED TO CONFIRM. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 CASE OF FALSE POSITIVE RESULTS USING MEDIA 442021 WITH LOT#: 2040814. ADDITIONAL INFORMATION RECEIVED: (B)(6) : 2022-05-25 20:09:41 (GMT). CUSTOMER REPORTS A TOTAL OF 2 VIALS AFFECTED WITH A FALSE POSITIVE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAD TWO FALSE POSITIVES. GRAM STAIN WAS PERFORMED TO CONFIRM. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 1 CASE OF FALSE POSITIVE RESULTS USING MEDIA 442021 WITH LOT#: 2040814. ADDITIONAL INFORMATION RECEIVED: (B)(6) : (B)(6) 2022 20:09:41 (GMT). CUSTOMER REPORTS A TOTAL OF 2 VIALS AFFECTED WITH A FALSE POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564214 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 2040814 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown