BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 16577494 · Received March 20, 2023

    Report

    Report Number
    3008352382-2023-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 4, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3008352382-2023-00025 WAS SENT IN ERROR REAGENT WAS NOT INVOLVED WITH THE FAILURE AND EVENT IS CAPTURED AGAINST THE INSTRUMENTS. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). PMA/510K INFO: K970512 K970333. 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 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS A NEGATIVE RESULT RELEASED EARLY WHEN IT HAD ONLY BEEN INCUBATED FOR 7 DAYS AND DID NOT COMPLETE THE TOTAL INCUBATION CYCLE. (42 DAYS). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EQUIPMENT RELEASES A FALSE-POSITIVE RESULT BEFORE COMPLETING THE TOTAL INCUBATION CYCLE (42 DAYS), WE CONTINUE THE MANUAL INCUBATION OF THE BLOOD CULTURES IN A BACTERIOLOGICAL CHAMBER AND WE CARRY OUT THE WEEKLY CONTROL UNTIL THE END OF THE CYCLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS A NEGATIVE RESULT RELEASED EARLY WHEN IT HAD ONLY BEEN INCUBATED FOR 7 DAYS AND DID NOT COMPLETE THE TOTAL INCUBATION CYCLE. (42 DAYS). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EQUIPMENT RELEASES A FALSE-POSITIVE RESULT BEFORE COMPLETING THE TOTAL INCUBATION CYCLE (42 DAYS), WE CONTINUE THE MANUAL INCUBATION OF THE BLOOD CULTURES IN A BACTERIOLOGICAL CHAMBER AND WE CARRY OUT THE WEEKLY CONTROL UNTIL THE END OF THE CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355913 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 2164960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown