BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17847772 · Received September 29, 2023

    Report

    Report Number
    2647876-2023-00211
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    August 31, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY. CATALOG: 442023. BATCH NO.: 3102704. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. 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.

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF A PATIENT SAMPLE. RESULT WAS REPORTED. POSSIBLY SKIN CONTAMINANT. TREATMENT CHANGE IS UNKNOWN AT THIS TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX 442023_3102728 - MOLECULAR FP PATIENT #1: (B)(6) 2023. SEQUENCE #: 449290746397. SN:(B)(6). BCID2 BIOFIRE LOT #: 2MGN22. BIOFIRE RESULT: STAPH EPI AND C. TROPICALIS. CULTURE: STAPH EPI AND YEAST - C. TROPICALIS. GRAM STAIN: ONLY GRAM POSITIVE COCCI AND NO YEAST. RESULT WAS REPORTED - COMMENT MADE "POSSIBLY SKIN CONTAMINANT"; CUSTOMER DOESN'T KNOW ABOUT TREATMENT CHANGE."

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE OF A PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. RESULT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX 442023_3102728 - MOLECULAR FP. PATIENT #2: ON (B)(6) 2023. LOT # 3102728. SEQUENCE #: (B)(6). SN: (B)(6). BCID2. BIOFIRE LOT #: 2MGN22. BIOFIRE RESULT: E. COLI + C. TROPICALIS. CULTURE: IN PROGRESS. GRAM STAIN : GRAM NEGATIVE RODS. RESULT WAS NOT REPORTED - REPEATED THE BIOFIRE, HAD A SECOND BOTTLE COME OFF AND THAT ONE ONLY HAD E. COLI ON IT AND ONLY REPORTED 2ND RUN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288242 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3102704 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other