BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 15392451 · Received September 9, 2022

    Report

    Report Number
    2647876-2022-00192
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 17, 2022
    Report Date
    September 25, 2022
    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

    DATE OF EVENT: NO EVENT OCCURRENCE DATE PROVIDED. USED AWARENESS DATE FROM GLOBAL COMPLAINT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER ADDR 1: (B)(6). PMA/510(K)#: K970512, K970333. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG 442288. BATCH NO. UNKNOWN . CUSTOMER REPORTED A CONTAMINATION DEFECT. 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. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. COMPLAINT IS UNCONFIRMED. NO CORRECTIVES 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THERE WERE THREE OCCURRENCES OF FALSE POSITIVE RESULTS DUE TO POSSIBLE CONTAMINATION. CONFIRMATORY TESTING WAS DONE VIA SLIDE OBSERVATION AND THE PRESENCE OF LOW QUANTITATIVE OF SPHERICAL BACTERIAL COCCI ASSOCIATED IN PAIRS, ALSO KNOWN AS DIPLOCOCCI, WAS OBSERVED. IN ADDITION, THE COMPLEMENTARY TEST TB MPT64 WAS PERFORMED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDIUM USED TO IDENTIFY MYCOBACTERIA, YEASTS OR FUNGI. HOWEVER, THE CUSTOMER NOTES THAT THE EQUIPMENT IS RELEASING POSITIVE RESULTS AND WHEN PERFORMING CONFIRMATORY TESTS, THESE TYPES OF MICROORGANISMS ARE NOT FOUND, BUT THE PRESENCE OF DIPLOCOCCI WAS OBSERVED. "THE DOCTOR REPORTED THAT OUR MYCO/F LYTIC MEDIUM BLOOD CULTURE BOTTLE IS RELEASING FALSE POSITIVE RESULTS. WHEN THE 9050 EQUIPMENT (SERIES N.: (B)(4)) RELEASES THE POSITIVE RESULT, SHE PERFORMS A CONFIRMATORY TEST VIA SLIDE OBSERVATION AND OBSERVES THE PRESENCE OF LOW QUANTITATIVE OF SPHERICAL BACTERIAL COCCI ASSOCIATED IN PAIRS ALSO KNOWN AS DIPLOCOCCI. IN ADDITION, PERFORMS THE COMPLEMENTARY TEST TB MPT64. COMPLEMENTARY MANUAL TESTS DO NOT IDENTIFY THE PRESENCE OF MYCOBACTERIA, YEASTS OR FUNGI, THE ONLY EVIDENCE IS THE PRESENCE OF DIPLOCOCCI. NOTE: THE CUSTOMER WAS UNABLE TO INFORM THE BATCH NUMBER OF THE VIALS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THERE WERE THREE OCCURRENCES OF FALSE POSITIVE RESULTS DUE TO POSSIBLE CONTAMINATION. CONFIRMATORY TESTING WAS DONE VIA SLIDE OBSERVATION AND THE PRESENCE OF LOW QUANTITATIVE OF SPHERICAL BACTERIAL COCCI ASSOCIATED IN PAIRS, ALSO KNOWN AS DIPLOCOCCI, WAS OBSERVED. IN ADDITION, THE COMPLEMENTARY TEST TB MPT64 WAS PERFORMED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDIUM USED TO IDENTIFY MYCOBACTERIA, YEASTS OR FUNGI. HOWEVER, THE CUSTOMER NOTES THAT THE EQUIPMENT IS RELEASING POSITIVE RESULTS AND WHEN PERFORMING CONFIRMATORY TESTS, THESE TYPES OF MICROORGANISMS ARE NOT FOUND, BUT THE PRESENCE OF DIPLOCOCCI WAS OBSERVED. "THE DOCTOR REPORTED THAT OUR MYCO/F LYTIC MEDIUM BLOOD CULTURE BOTTLE IS RELEASING FALSE POSITIVE RESULTS. WHEN THE 9050 EQUIPMENT (SERIES N.:(B)(6) RELEASES THE POSITIVE RESULT, SHE PERFORMS A CONFIRMATORY TEST VIA SLIDE OBSERVATION AND OBSERVES THE PRESENCE OF LOW QUANTITATIVE OF SPHERICAL BACTERIAL COCCI ASSOCIATED IN PAIRS ALSO KNOWN AS DIPLOCOCCI. IN ADDITION, PERFORMS THE COMPLEMENTARY TEST TB MPT64. COMPLEMENTARY MANUAL TESTS DO NOT IDENTIFY THE PRESENCE OF MYCOBACTERIA, YEASTS OR FUNGI, THE ONLY EVIDENCE IS THE PRESENCE OF DIPLOCOCCI. NOTE: THE CUSTOMER WAS UNABLE TO INFORM THE BATCH NUMBER OF THE VIALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306541 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown