BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17421346 · Received July 28, 2023

    Report

    Report Number
    2647876-2023-00089
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.6 INITIAL REPORTER E-MAIL: (B)(6). G.6 PMA / 510(K)#: K113558, K222591. H.3. 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

    H.6. INVESTIGATION SUMMARY: CATALOG 442023, BATCH NO. 3062849. CUSTOMER REPORTED A DUPLICATED BARCODE SEQUENCES WITHIN THE SAME BATCH NUMBERS. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR REPEATED SEQUENCE (NONE OF THE VIAL LABEL SEQUENCE NUMBERS WERE REPEATED). BATCH HISTORY RECORD WAS REVIEWED. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING THE INCIDENT TO THE LOT NUMBER. COMPLAINTS IS CONFIRMED. USERS SHOULD VERIFY THAT THE ACCESSION NUMBER ON THE BD BACTEC¿ INSTRUMENT LOADING SCREEN MATCHES THE VIAL'S ACCESSION NUMBER WHILE SCANNING AND LOADING ONTO THE INSTRUMENT. IF AN ERROR MESSAGE OR OTHER SYSTEM ACTION OCCURS WHEN LOADING VIALS INTO THE BD BACTEC¿ INSTRUMENT THAT INDICATES A POTENTIAL ISSUE WITH DUPLICATE SEQUENCE NUMBERS, IT IS RECOMMENDED TO FOLLOW THE INSTRUCTIONS WITHIN THE MESSAGE AND TO VIEW THE TABLE OF ¿SYSTEM ALERTS¿ LOCATED IN 7 ¿ TROUBLESHOOTING OF THE BD BACTEC¿ FX INSTRUMENT USER¿S MANUAL BEFORE TAKING ANY FURTHER ACTION IN VIAL PROCESSING. REFER TO PRODUCT ADVISORY NOTIFICATION. CORRECTIVE ACTIONS PREVENTIVE ACTIONS (CAPA) WAS INITIATED TO DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE OCCURRENCE. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), A BOTTLE HAD THE SAME SEQUENCE NUMBER AS ANOTHER BOTTLE WITHIN THE SAME BATCH. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE IS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. HAVE INSTRUMENT LOG FILES BEEN OBTAINED AND REVIEWED? -- I DO NOT HAVE INSTRUMENT LOG FILES. 2. HAS AN APPLICATION SPECIALIST REACHED OUT TO THE CUSTOMER TO REVIEW CUSTOMER WORKFLOW? -- YES AND ALL IS NORMAL WE HAVE THE SAME CASE FOR 5 OTHER SEQUENCE NUMBER. THE CUSTOMER ENTERED A FIRST VIAL WITH SEQUENCE NUMBER (B)(4) FROM LOT 3062849 EXP DATE 08/12/2023 ON (B)(6) 2023 AT 10:54. AND THEN HE ENTERED A SECOND VIAL WITH THE SAME SEQUENCE NUMBER (B)(4) FROM LOT 3062849 EXP DATE 08/12/2023 ON (B)(6) 2023 AT 20:44. THE CUSTOMER DOESN'T UNDERSTAND HOW IT'S POSSIBLE TO HAVE THE SAME BOTTLE SEQUENCE NUMBER TWICE IN THE SAME BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE IS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. HAVE INSTRUMENT LOG FILES BEEN OBTAINED AND REVIEWED? -- I DO NOT HAVE INSTRUMENT LOG FILES. 2. HAS AN APPLICATION SPECIALIST REACHED OUT TO TO THE CUSTOMER TO REVIEW CUSTOMER WORKFLOW? -- YES AND ALL IS NORMAL WE HAVE THE SAME CASE FOR 5 OTHER SEQUENCE NUMBER. THE CUSTOMER ENTERED A FIRST VIAL WITH SEQUENCE NUMBER 449270866677 FROM LOT 3062849 EXP DATE 08/12/2023 ON 07/07/2023 AT 10:54. AND THEN HE ENTERED A SECOND VIAL WITH THE SAME SEQUENCE NUMBER 449270866677 FROM LOT 3062849 EXP DATE 08/12/2023 ON 07/07/2023 AT 20:44. THE CUSTOMER DOESN'T UNDERSTAND HOW IT'S POSSIBLE TO HAVE THE SAME BOTTLE SEQUENCE NUMBER TWICE IN THE SAME BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), A BOTTLE HAD THE SAME SEQUENCE NUMBER AS ANOTHER BOTTLE WITHIN THE SAME BATCH. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966247 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3062849 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown