BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17220326 · Received June 28, 2023

    Report

    Report Number
    2647876-2023-00059
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 12, 2023
    Report Date
    August 8, 2023
    Manufacturer
    BD CARIBE, LTD
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG 442023. BATCH NO. 3041885. CUSTOMER REPORTED A FALSE NEGATIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN TESTED FOR MICROBIAL INSTRUMENT DETECTION AS PER QUALITY PROCEDURES. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT (I.E. FALSE NEGATIVE). MICROBIAL INSTRUMENT DETECTION INDICATED THAT THE PRODUCT IS PERFORMING AS EXPECTED. 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 RECORD REVIEW RESULTS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 3041885. D.4. MEDICAL DEVICE EXPIRATION DATE: 17/11/2023 . H.4. DEVICE MANUFACTURE DATE: 10/02/2023.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE AEROBIC BOTTLE FLAGGED AS FALSE NEGATIVE. THIS OCCURRED ON ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ISOLATED A P. AERUGINOSA FROM THE LYTIC BOTTLE, BUT NOT THE AEROBIC BOTTLE OF A BLOOD CULTURE SET. THE AEROBIC BOTTLE WAS REPORTED AS NEGATIVE AT 5 DAYS INCUBATION. FROM CUSTOMER: DID THE LYTIC BOTTLE FLAG POSITIVE IN THE INSTRUMENT? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? THIS RESULT WAS REPORTED TO THE CLINICIANS. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO, CUSTOMER WAS TREATED ON THE LYTIC BOTTLE RESULT. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? CUSTOMER BELIEVES THE PSEUDOMONAS WAS A VALID RESULT AND THE PATIENT TREATED ACCORDINGLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE AEROBIC BOTTLE FLAGGED AS FALSE NEGATIVE. THIS OCCURRED ON ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ISOLATED A P. AERUGINOSA FROM THE LYTIC BOTTLE, BUT NOT THE AEROBIC BOTTLE OF A BLOOD CULTURE SET. THE AEROBIC BOTTLE WAS REPORTED AS NEGATIVE AT 5 DAYS INCUBATION. FROM CUSTOMER: DID THE LYTIC BOTTLE FLAG POSITIVE IN THE INSTRUMENT? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? THIS RESULT WAS REPORTED TO THE CLINICIANS. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO, CUSTOMER WAS TREATED ON THE LYTIC BOTTLE RESULT . IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? CUSTOMER BELIEVES THE PSEUDOMONAS WAS A VALID RESULT AND THE PATIENT TREATED ACCORDINGLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THE AEROBIC BOTTLE FLAGGED AS FALSE NEGATIVE. THIS OCCURRED ON ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ISOLATED A P. AERUGINOSA FROM THE LYTIC BOTTLE, BUT NOT THE AEROBIC BOTTLE OF A BLOOD CULTURE SET. THE AEROBIC BOTTLE WAS REPORTED AS NEGATIVE AT 5 DAYS INCUBATION. FROM CUSTOMER: DID THE LYTIC BOTTLE FLAG POSITIVE IN THE INSTRUMENT? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? THIS RESULT WAS REPORTED TO THE CLINICIANS. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO, CUSTOMER WAS TREATED ON THE LYTIC BOTTLE RESULT. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? CUSTOMER BELIEVES THE PSEUDOMONAS WAS A VALID RESULT AND THE PATIENT TREATED ACCORDINGLY.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701753 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BD CARIBE, LTD 442023 3041885 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown