BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 12911552 · Received December 1, 2021

    Report

    Report Number
    2647876-2021-00304
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    PMA / PMN Number
    K970512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K970333. 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

    INVESTIGATION SUMMARY: BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. PHOTO WAS NOT PROVIDED. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR BOTTLE INTEGRITY (I.E. BROKEN/CRACKED BOTTLES). 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 RECORD REVIEW RESULTS. THE CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT ARE: A 100% VISUAL INSPECTION PERFORMED DURING THE PACKAGING PROCESS IN ORDER TO DETECT BOTTLE DAMAGE. ALSO, DURING THE PACKAGING PROCESS OF EACH LOT, A PROCESS CONTROL REPRESENTATIVE INSPECTS 1 CASE EVERY 30 MINUTES FOR COMPLETENESS. PRODUCT INSERT WARNING AND PRECAUTIONS STATES THAT PRIOR USE, THE USER SHOULD EXAMINE THE VIALS FOR EVIDENCE OF DAMAGE OR DETERIORATION. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THE BOTTLE BROKE WITH (B)(6) SAMPLE INSIDE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GLASS BOTTLE BREAKAGE WITH (B)(6) SAMPLE INSIDE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THE BOTTLE BROKE WITH POSITIVE TB SAMPLE INSIDE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GLASS BOTTLE BREAKAGE WITH TB POSITIVE SAMPLE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810615 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 1055279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown