BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14289592 · Received May 5, 2022

    Report

    Report Number
    2647876-2022-00121
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1270329, MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2022, DEVICE MANUFACTURE DATE: 27-SEP-2021. MEDICAL DEVICE LOT #: 1321553, MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2022, DEVICE MANUFACTURE DATE: 17-NOV-2021. MEDICAL DEVICE LOT #: 1342226, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2022, DEVICE MANUFACTURE DATE: 08-DEC-2021. MEDICAL DEVICE LOT #: 1223442, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2022, DEVICE MANUFACTURE DATE: 11-AUG-2021. DEVICE EVALUATED BY MFR: 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: CUSTOMER REPORTED BUBBLES IN THE SENSOR OF THE BOTTLE AND A FALSE POSITIVE RESULTS. THREE OUT OF FOUR PHOTOS RECEIVED SHOWED TINY BUBBLES IN THE SENSOR. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED FOR WITH SATISFACTORY RESULTS. ALL RETENTION SAMPLES HAVE TINY AIR BUBBLES IN THE SENSOR. BLOOD BACKGROUND TEST WAS PERFORMED FOR FALSE POSITIVE CLAIM WITH SATISFACTORY RESULTS. 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 RECORDS REVIEW FOR. THIS COMPLAINT SHOULD BE CONSIDERED AS AN EDUCATIONAL ISSUE SINCE THESE TINY AIR BUBBLES OBSERVED AT THE BOTTOM AND/OR SIDE OF THE SENSOR IS CAUSED BY THE OUT GASSING OF THE WATER VAPOR DURING THE SENSOR CURING PROCESS. THE PRESENCE OF THESE AIR BUBBLES SHOULD NOT HAVE ANY ADVERSE EFFECT IN SENSOR PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL (PLASTIC) EACH FROM LOTS 1270329, 1321553, 1342226, AND 1223442 PRODUCED FALSE POSITIVE RESULTS. SUBCULTURES AND GRAM-STAINS WERE PERFORMED BEFORE REPORTING RESULTS TO CLINICIANS, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER IS EXPERIENCING... INCREASED FALSE POSITIVE VIALS (COMPLAINT ID (B)(4)." "EXTRA WORK FOR THE LAB AS AFFECTED BOTTLES NEED TO BE MOVED, SUBCULTURED, GRAM-STAINED AND/OR INCUBATED OFFLINE. NO PATIENT IMPACT, CONFIRMATORY TESTS ARE ALWAYS PERFORMED BEFORE REPORTING RESULTS TO CLINICIANS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL (PLASTIC) EACH FROM LOTS 1270329, 1321553, 1342226, AND 1223442 PRODUCED FALSE POSITIVE RESULTS. SUBCULTURES AND GRAM-STAINS WERE PERFORMED BEFORE REPORTING RESULTS TO CLINICIANS, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER IS EXPERIENCING...INCREASED FALSE POSITIVE VIALS (COMPLAINT ID 4623038)." "EXTRA WORK FOR THE LAB AS AFFECTED BOTTLES NEED TO BE MOVED, SUBCULTURED, GRAM-STAINED AND/OR INCUBATED OFFLINE. NO PATIENT IMPACT, CONFIRMATORY TESTS ARE ALWAYS PERFORMED BEFORE REPORTING RESULTS TO CLINICIANS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693171 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE SECTION H10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown