BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 17990965 · Received October 23, 2023

    Report

    Report Number
    2647876-2023-00334
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS UNCONFIRMED. THE CUSTOMER WAS NOTICED THAT AEROBIC VIAL (CAT# 442023, LOT# 3046180) THAT INSERTED TO THE BACTEC ON THE 19.09.23 AND GOT POSITIVE RESULT ON THE 21.09.23 WAS FOUND WITH THE SAME SEQ# AS A VIAL FROM AUGUST (449273485916). PHOTOS RECEIVED SHOWED MULTIPLE ALERTS PROVIDED BY THE FX AND EPICENTER BY SEP'23. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. QUALITY CONTROL DEPARTMENT PERFORMED A VISUAL INSPECTION AND AN INSTRUMENT VIAL ENTRY TEST TO ALL RETENTION SAMPLES (BACTEC FX INSTRUMENT). BARCODE SEQUENCE NUMBERS WERE NOT REPEATED DURING THE RETENTION SAMPLES EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K222591. H.3. A 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 WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS INCORRECT LABEL INFORMATION ASSOCIATED WITH ONE VIAL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER NOTICED THAT AEROBIC VIAL (CAT# 442023, LOT# 3046180) THAT INSERTED TO THE BACTEC ON THE 19.09.23 AND GOT POSITIVE RESULT ON THE 21.09.23 WAS FOUND WITH THE SAME SEQ# AS A VIAL FROM AUGUST (449273485916). AS A RESULT OF THIS DUPLICATION IN THE SEQ# THE TEST RESULT (POSITIVE) WAS SENT TO THE LIST FOR DIFFERENT PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS INCORRECT LABEL INFORMATION ASSOCIATED WITH ONE VIAL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER NOTICED THAT AEROBIC VIAL (CAT# 442023, LOT# 3046180) THAT INSERTED TO THE BACTEC ON THE 19.09.23 AND GOT POSITIVE RESULT ON THE 21.09.23 WAS FOUND WITH THE SAME SEQ# AS A VIAL FROM AUGUST (449273485916). AS A RESULT OF THIS DUPLICATION IN THE SEQ# THE TEST RESULT (POSITIVE) WAS SENT TO THE LIS FOR DIFFERENT PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856056 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3046180 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown