BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML

    MDR report key: 11216503 · Received January 22, 2021

    Report

    Report Number
    1111096-2021-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    October 19, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    MDB
    UDI-DI
    30382902451229
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT#1111096-2021-00001 WAS SENT IN ERROR. QC FAILURE IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, EXPERIENCED DELAYED QC GROWTH WITH M KANSASII AND M TB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: QC DELAYED GROWTH. M KANSASII AND M TB ARE COMING UP A DAY OR TWO LATER THAN EXPECTED. ISSUE WAS RESOLVED WITH NEW QC ORGANISMS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BD BBL" MGIT" MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML, EXPERIENCED DELAYED QC GROWTH WITH (B)(6). THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: QC DELAYED GROWTH. (B)(6) ARE COMING UP A DAY OR TWO LATER THAN EXPECTED. ISSUE WAS RESOLVED WITH NEW QC ORGANISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109620 BD BBL MGIT MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. 245122 UNKNOWN 30382902451229

    Patients

    Seq Age Sex Outcome Treatment
    1