BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC; PLUS AEROBIC/F CULTURE VIALS

    MDR report key: 11348353 · Received February 19, 2021

    Report

    Report Number
    3008352382-2021-00046
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BECTON DICKINSON 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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO. 0191262. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN TESTED FOR MICROBIAL INSTRUMENT DETECTION. ALSO, GRAM STAIN WAS PERFORMED WITH SATISFACTORY RESULTS. BATCH AND SENSOR HISTORY RECORDS REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. H. INFLUENZAE GREW AT 18; 06 (HH;MM) HRS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH RECORD REVIEW RESULTS. QUALITY CONTROL CERTIFICATES LIST TEST ORGANISM, INCLUDING ATCC¿ CULTURE SPECIFIED IN THE CLSI STANDARD M22, QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA FOR EXPECTED ATCC PERFORMANCE. NO CORRECTIVE ACTIONS WERE REQUIRED. CATALOG 442023. BATCH NO. 9319966 EXPIRED & 0087005 EXPIRED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. NO INVESTIGATION WILL BE CONDUCTED. BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR PRODUCT RELEASE. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. 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

    IT WAS REPORTED WHILE USING BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS H. INFUENZAE WOULD NOT GROW IN 3 LOTS.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9319966, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2019-11-15. MEDICAL DEVICE LOT #: 0087005, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2020-03-27. MEDICAL DEVICE LOT #: 0191262, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2020-07-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS H. INFUENZAE WOULD NOT GROW IN 3 LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249200 BD BACTEC; PLUS AEROBIC/F CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H.10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1