BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 14628484 · Received June 7, 2022

    Report

    Report Number
    1119779-2022-00830
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2040762. MEDICAL DEVICE EXPIRATION DATE: 30 NOV 2022. DEVICE MANUFACTURE DATE: 19 FEB 2022. MEDICAL DEVICE LOT #: 20400768. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 20400768 WAS REPORTED BUT IS NOT VALID FOR THIS PRODUCT. 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

    THE INITIAL SECOND LOT NUMBER FOR THE PRODUCT WAS NOT VALID. THE CORRECT LOT NUMBER HAS BEEN PROVIDED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2040762 D.4. MEDICAL DEVICE EXPIRATION DATE: 30 NOV 2022 H.4. DEVICE MANUFACTURE DATE: 19 FEB 2022 D.4. MEDICAL DEVICE LOT #: 2040768 D.4. MEDICAL DEVICE EXPIRATION DATE: 30 NOV 2022 H.4. DEVICE MANUFACTURE DATE: 19 FEB 2022 H3 SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6: CATALOG 442021; BATCH NO. 2040762/2040768. CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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. USERS ARE CAUTIONED IN THE PACKAGE INSERT UNDER LIMITATION OF THE PROCEDURE: ¿A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBER OF NON-VIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDE AND SPECIMENS USED FOR INOCULATION. THERE ARE MANY FACTORS THAT CAN INFLUENCE THE FALSE POSITIVE RATE, INCLUDING BLOOD VOLUME, BLOOD CELL COUNTS, ENVIRONMENTAL FACTORS, AND MEDIA LOT TO LOT VARIATIONS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW. 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 HAS BEEN REPORTED THAT THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF PRODUCING FALSE POSITIVE RESULTS. GRAM STAINING WAS USED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 3 VIALS SHOWING POSITIVE ON THE INSTRUMENT BUT NEGATIVE AFTER GRAM STAIN. THE INSTRUMENT HAD A PREVIOUS "GAP READING ALERT" (PLEASE SEE CASE: (B)(4)). ALL OF THE VIALS ON THE INSTRUMENT WERE SUBCULTURE 44 IN TOTAL AND PROTOCOL WAS RESUMED. 3 OF THE VIALS GAVE A "POSITIVE RESULT", HOWEVER AFTER GRAM STAIN, NO MICROORGANISM WAS DETECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF PRODUCING FALSE POSITIVE RESULTS. GRAM STAINING WAS USED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 3 VIALS SHOWING POSITIVE ON THE INSTRUMENT BUT NEGATIVE AFTER GRAM STAIN. THE INSTRUMENT HAD A PREVIOUS "GAP READING ALERT" (PLEASE SEE CASE: (B)(4). ALL OF THE VIALS ON THE INSTRUMENT WERE SUBCULTURE 44 IN TOTAL AND PROTOCOL WAS RESUMED. 3 OF THE VIALS GAVE A "POSITIVE RESULT", HOWEVER AFTER GRAM STAIN, NO MICROORGANISM WAS DETECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF PRODUCING FALSE POSITIVE RESULTS. GRAM STAINING WAS USED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 3 VIALS SHOWING POSITIVE ON THE INSTRUMENT BUT NEGATIVE AFTER GRAM STAIN. THE INSTRUMENT HAD A PREVIOUS "GAP READING ALERT" (PLEASE SEE CASE: (B)(4)). ALL OF THE VIALS ON THE INSTRUMENT WERE SUBCULTURE 44 IN TOTAL AND PROTOCOL WAS RESUMED. 3 OF THE VIALS GAVE A "POSITIVE RESULT", HOWEVER AFTER GRAM STAIN, NO MICROORGANISM WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197450 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 442021 SEE H.10 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown