BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14306562 · Received May 6, 2022

    Report

    Report Number
    2647876-2022-00126
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1167767. MEDICAL DEVICE EXPIRATION DATE: 31MAR2022. DEVICE MANUFACTURE DATE: 16JUN2021. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. 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. NO ADDITIONAL TESTING IS REQUIRED AT THIS TIME. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A MOLECULAR TEST INDICATED THE PRESENCE OF ALTERNATIVE PATHOGENS. CONFIRMATORY TESTING WAS PERFORMED USING GRAM STAINING. THE FOLLOWING MATERIAL AND LOT #'S WERE REPORTED TO BE EFFECTED: MATERIAL # 442022 ¿ LOT #¿S 1167259 / 1175560. MATERIAL # 442023 ¿ LOT #¿S 1167767 / 1181333. TOTAL 15 FALSE POSITIVES SPLIT AMONG THESE MATERIAL #¿S AND LOT #¿S. SEPARATE MDR SUBMITTED FOR EACH MATERIAL #. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 04/26/2022: INITIAL REPORT AND ADDITIONAL INFORMATION. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN (B)(6) 2021 AND READILY AVAILABLE FOR USE. ON (B)(6) 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM NEGATIVE BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. CONTAMINATION BY NON-VIABLE MICROORGANISMS OF THE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX IN BD FLASKS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) A MOLECULAR TEST INDICATED THE PRESENCE OF ALTERNATIVE PATHOGENS. CONFIRMATORY TESTING WAS PERFORMED USING GRAM STAINING. THE FOLLOWING MATERIAL AND LOT #'S WERE REPORTED TO BE EFFECTED: MATERIAL # 442022 ¿ LOT #¿S 1167259 / 1175560 MATERIAL # 442023 ¿ LOT #¿S 1167767 / 1181333 TOTAL 15 FALSE POSITIVES SPLIT AMONG THESE MATERIAL #¿S AND LOT #¿S. SEPARATE MDR SUBMITTED FOR EACH MATERIAL #. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 04/26/2022: INITIAL REPORT AND ADDITIONAL INFORMATION. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN NOVEMBER 2021 AND READILY AVAILABLE FOR USE. ON NOVEMBER 5, 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM NEGATIVE BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. CONTAMINATION BY NON-VIABLE MICROORGANISMS OF THE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX IN BD FLASKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099416 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1181333 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown