BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 18040942 · Received October 31, 2023

    Report

    Report Number
    2647876-2023-00388
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    September 18, 2023
    Report Date
    December 8, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442021. BATCH NO.: 3130610. 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 RECORDS REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCHES HAVE BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORDS REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    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

    REPORT 3 OF 12. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE WITH C.TROP. LOT NUMBER AFFECTED BASED ON OCCURRENCE DATE: 3130610 (B)(6) 2024 . HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C.TROP 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) S. EPI, BACILLUS SPECIES ,ANAEROCOCCUS SPECIES, ANAEROBIC GNR, LACTOBACILLUS, E. COLI , S. PARASANGUINIS, CNS 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS?NO 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT?NO".

    Description of Event or Problem · 0

    REPORT 3 OF 12. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A MOLECULAR FALSE POSITIVE WITH C.TROPICALIS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE WITH C.TROP. LOT NUMBER AFFECTED BASED ON OCCURRENCE DATE: 3130610 "(B)(6) 2024". HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? C.TROP. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) S. EPI, BACILLUS SPECIES ,ANAEROCOCCUS SPECIES, ANAEROBIC GNR, LACTOBACILLUS, E. COLI , S. PARASANGUINIS, CNS. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? NO. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT?NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101362 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130610 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown