BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16892175 · Received May 8, 2023

    Report

    Report Number
    2647876-2023-00028
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    January 10, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442023 BATCH NO.: 3011325 CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. 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 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. CATALOG: 442023 BATCH NO.: 3003216 CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. 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. SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3003216. D4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2023. H4. DEVICE MANUFACTURE DATE: (B)(6) 2023. 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

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3011325. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE AN UNSPECIFIED NUMBER OF MOLECULAR FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.

    Description of Event or Problem · 0

    IIT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WERE MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ CUSTOMER PROBLEM: CUSTOMER REPORTS THEIR BIOFIRE KEEPS GIVING A FALSE POSITIVE RESULT FOR CANDIDA TROPICALIS. LOT#: 3003216 AND LOT#: 3011325. ¿ QUANTITY RECEIVED AND QUANTITY AFFECTED: AT LEAST 20 BOTTLES AFFECTED. ¿ WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. CUSTOMER REPORTS THEIR BIOFIRE KEEPS GIVING A FALSE POSITIVE RESULT FOR CANDIDA TROPICALIS. LOT#: 3003216 AND LOT#: 3011325.

    Description of Event or Problem · 0

    IIT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WERE MOLECULAR FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS THEIR BIOFIRE KEEPS GIVING A FALSE POSITIVE RESULT. FOR CANDIDA TROPICALIS. LOT#: 3003216 AND LOT#: 3011325. QUANTITY RECEIVED AND QUANTITY AFFECTED: AT LEAST 20 BOTTLES AFFECTED. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. CUSTOMER REPORTS THEIR BIOFIRE KEEPS GIVING A FALSE POSITIVE RESULT FOR CANDIDA TROPICALIS. LOT#: 3003216, AND LOT#: 3011325.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE AN UNSPECIFIED NUMBER OF MOLECULAR FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639071 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 3011325 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown