BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15443665 · Received September 19, 2022

    Report

    Report Number
    2647876-2022-00194
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 6, 2022
    Report Date
    February 15, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: CATALOG 442021. BATCH NO. 2070284. CUSTOMER REPORTED A PAENIBACILLUS CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. A LIST OF BARCODES SEQUENCES WAS RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH BACTEC 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. SEVERAL EVALUATIONS WERE PERFORMED TO CONCLUDE THAT THE BIO-CONTAMINANT PAENIBACILLUS DID NOT ORIGINATED FROM BD MANUFACTURING SITE. THE AUTOCLAVE PROCESS WAS EVALUATED. THE MOIST HEAT AUTOCLAVE IS A PROCESS THAT USES MOIST HEAT AS THE LETHAL AGENT TO RENDER LIQUID AND POROUS/HARD GOODS ITEMS FREE FROM VIABLE MICROORGANISM AND RELIES ON DIRECT CONTACT WITH SATURATED STEAM, WHICH IS WATER VAPOR IN EQUILIBRIUM WITH LIQUID WATER. THE AUTOCLAVE PROCESS IS ACCOMPLISHED BY THE HEAT TRANSFER FROM THE STEAM TO THE LOAD AND BY HYDRATING EFFECT OF THE RESULTANT CONDENSATE THAT FORMS DUE TO THE CHANGE IN STATE FROM VAPOR TO THE LOWER ENERGY LIQUID STATE. THIS PHASE CHANGE REQUIRES THE TRANSFER OF THE LATENT HEAT OF THE STEAM TO THE SURROUNDINGS, THUS HEATING THE AUTOCLAVE AND ITS LOAD. BD CAYEY AUTOCLAVE THE PRODUCTS VIA MOIST HEAT. INITIAL VALIDATION HAD BEEN SUCCESSFULLY COMPLETED AND THE REQUIRED REQUALIFICATION ASSESSMENT HAS BEEN PERFORMED ACCORDINGLY MAINTAINING THE ACTIVE AND VALID AUTOCLAVING CYCLE. ENVIRONMENTAL SAMPLES WERE EVALUATED FROM BD MANUFACTURING SITE FOR IDENTIFICATION OF BACTERIAL SPECIES PRESENT AT DIFFERENT LOCATIONS WITHIN THE MANUFACTURING PLANT. THE PURPOSE OF IDENTIFYING THESE ISOLATES WAS TO DETERMINE IF PAENIBACILLUS CONTAMINATION ORIGINATED FROM THIS LOCATION. AFTER PERFORMING MALDI TESTING NONE OF THE ENVIRONMENTAL SAMPLES COLLECTED FROM DIFFERENT LOCATIONS WITHIN THE MANUFACTURING PLANT IN BD CAYEY WERE IDENTIFIED AS PAENIBACILLUS. THEREFORE, THE BIO-CONTAMINANT PAENIBACILLUS LIKELY DID NOT ORIGINATE FROM THE BD CAYEY, AND THERE IS NO EVIDENCE TO INDICATE THAT IT WOULD IT HAVE SURVIVED THE AUTOCLAVING PROCESS OF BACTEC BOTTLES. 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. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS CONTAMINATION DUE TO ISOLATION OF PAENIBACILLUS URINALIS GROUP FROM SEVERAL BOTTLES. THE CUSTOMER PERFORMED GRAM STAIN AND ORGANISM ID USING BRUKER MALDI. POSITIVE BOTTLES WERE PLATED TO AGAR PLATES. THERE WAS 1 OCCURRENCE OF CONTAMINATION FOR THIS COMPLAINT. THE SUSPECTED CONTAMINANT ISOLATE WAS REPORTED OUT AND A REVIEW IS UNDERWAY TO FIND OUT IF PATIENTS WERE TREATED. THERE WAS NO ADVERSE REACTION REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES CONTAMINATED BOTTLES DUE TO ISOLATION OF PAENIBACILLUS URINALIS GROUP FROM SEVERAL BOTTLES. CUSTOMER PERFORMED GRAM STAIN AND ORGANISM ID USING BRUKER MALDI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS CONTAMINATION DUE TO ISOLATION OF PAENIBACILLUS URINALIS GROUP FROM SEVERAL BOTTLES. THE CUSTOMER PERFORMED GRAM STAIN AND ORGANISM ID USING BRUKER MALDI. POSITIVE BOTTLES WERE PLATED TO AGAR PLATES. THERE WAS 1 OCCURRENCE OF CONTAMINATION FOR THIS COMPLAINT. THE SUSPECTED CONTAMINANT ISOLATE WAS REPORTED OUT AND A REVIEW IS UNDERWAY TO FIND OUT IF PATIENTS WERE TREATED. THERE WAS NO ADVERSE REACTION REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES CONTAMINATED BOTTLES DUE TO ISOLATION OF PAENIBACILLUS URINALIS GROUP FROM SEVERAL BOTTLES. CUSTOMER PERFORMED GRAM STAIN AND ORGANISM ID USING BRUKER MALDI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394260 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 2070284 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown