BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13601984 · Received February 25, 2022

    Report

    Report Number
    2647876-2022-00029
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 7, 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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-08. H6: INVESTIGATION SUMMARY CUSTOMER REPORTED SENSOR ADHESION AND A FALSE POSITIVE RESULT. ONE PHOTO WAS RECEIVED WITH SENSOR ADHESION DEFECT. RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. RETENTION AND RETURNED GOOD SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. BLOOD BACKGROUND WAS PERFORMED WITH SATISFACTORY RESULTS FOR THE FALSE POSITIVE CLAIM. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS CONFIRMED FOR SENSOR ADHESION DEFECT BASED ON PHOTOS RECEIVED. THE VISION SYSTEM IS CHALLENGED PRIOR EACH LOT. 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. CORRECTIVE ACTIONS PREVENTIVE ACTIONS (CAPA) 2882676 WAS INITIATED TO FURTHER INVESTIGATE THESE TYPES OF COMPLAINTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED A FALSE POSITIVE RESULT. GRAM STAINS WERE PERFORMED BUT NOTHING GREW IN THE SUBCULTURE PLATES. THE BOTTLE WAS TESTED AGAIN IN THE MAIN LAB, WITH THE RESULT POSITIVE ONCE MORE. THERE WAS NO INDICATION THAT THE ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING 2 BOTTLES FROM LOTS 1223437 AND 1245110 THAT WENT FALSE POSITIVE... BOTH BOTTLES WERE GRAM STAINED AND SUBCULTURED. NO ORGANISMS WERE SEEN ON THE GRAM STAIN AND NOTHING GREW IN CULTURE. BOTTLES HAVE BEEN INCUBATED MANUALLY BECAUSE THEY CAN NOT BE PUT BACK IN BACTEC WITHOUT GOING POSITIVE. BOTTLES ORIGINALLY WENT POSITIVE AT HOSPITAL LAB AND THEY WERE SENT TO THEIR MAIN LAB FOR REVIEW. THE MAIN LAB PLACED THE BOTTLES IN THEIR BACTEC INSTRUMENTS AND THE BOTTLES WENT IMMEDIATELY POSITIVE. NO PATIENT SAMPLES WERE AFFECTED DUE TO THE FALSE POSITIVES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) PRODUCED A FALSE POSITIVE RESULT. GRAM STAINS WERE PERFORMED BUT NOTHING GREW IN THE SUBCULTURE PLATES. THE BOTTLE WAS TESTED AGAIN IN THE MAIN LAB, WITH THE RESULT POSITIVE ONCE MORE. THERE WAS NO INDICATION THAT THE ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING 2 BOTTLES FROM LOTS 1223437 AND 1245110 THAT WENT FALSE POSITIVE... BOTH BOTTLES WERE GRAM STAINED AND SUBCULTURED. NO ORGANISMS WERE SEEN ON THE GRAM STAIN AND NOTHING GREW IN CULTURE. BOTTLES HAVE BEEN INCUBATED MANUALLY BECAUSE THEY CAN NOT BE PUT BACK IN BACTEC WITHOUT GOING POSITIVE. BOTTLES ORIGINALLY WENT POSITIVE AT HOSPITAL LAB AND THEY WERE SENT TO THEIR MAIN LAB FOR REVIEW. THE MAIN LAB PLACED THE BOTTS IN THEIR BACTEC INSTRUMENTS AND THE BOTTLES WENT IMMEDIATELY POSITIVE... NO PATIENT SAMPLES WERE AFFECTED DUE TO THE FALSE POSITIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196243 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1245110 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown