BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18059966 · Received November 2, 2023

    Report

    Report Number
    2647876-2023-00404
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 13, 2023
    Report Date
    December 29, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. D4. MEDICAL DEVICE LOT#:UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CATALOG: 442023 BATCH NO.: UNKNOWN CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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. COMPLAINT IS UNCONFIRMED. REFER TO CUSTOMER LETTER. 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 INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    3012712 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: K113558, 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 2 OF 3, IT WAS REPORTED WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THREE MOLECULAR FALSE POSITIVES WITH THE ORGANISM C. TROPICALIS WERE OBTAINED. THERE WAS NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 3 IT WAS REPORTED WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THREE MOLECULAR FALSE POSITIVES WITH THE ORGANISM C. TROPICALIS WERE OBTAINED. THERE WAS NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THREE MOLECULAR FALSE POSITIVES WITH THE ORGANISM C. TROPICALIS WERE OBTAINED. THERE WAS NO PATIENT IMPACT REPORTED. REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284351 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown