BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 17560986 · Received August 16, 2023

    Report

    Report Number
    2647876-2023-00099
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 12, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    PMA / PMN Number
    K970512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN; D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; E.1. INITIAL REPORTER PHONE #: (B)(6); G.5. K970333; H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: CATALOG 442288; BATCH NO. UNKNOWN. CUSTOMER REPORTED A CONTAMINATED BOTTLE FELL ON THE FLOOR AND BROKE. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED. NO CORRECTIVES ACTIONS WERE REQUIRED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 1 OF 2 IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS, ONE BOTTLE CONTAINING PATIENT SAMPLE FELL ON THE FLOOR. ONE END USER WAS NOT WEARING PPE, HOWEVER, HAS TESTED NEGATIVE ON QUANTIFERON EXAMS. NO ADDITIONAL IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD BACTEC MYCO/F GLASS BOTTLE, POSITIVE FOR MYCOBACTERIUM TUBERCULOSIS, FELL TO THE FLOOR AND BROKE WHEN REMOVED FROM THE EQUIPMENT. NO PPE WAS BEING USED AT THE TIME. HOWEVER, IN THE SEQUENCE, THEY PUT ON AN N95 MASK AND GLOVES TO BE ABLE TO CONTAIN THE LIQUID WITH ABSORBENT PAPER. THE COLLABORATORS ARE BEING ASSISTED BY THE OCCUPATIONAL MEDICINE AND UNDERWENT X-RAY AND QUANTIFERON EXAMS. ONE OF THEM HAS NEGATIVE TESTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895262 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown