BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24177264 · Received January 26, 2026

    Report

    Report Number
    2647876-2026-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 25, 2026
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    30382904420223
    PMA / PMN Number
    K141810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME. INVESTIGATION SUMMARY: CATALOG 442022, BATCH NO. 5182381. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE 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. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. PRODUCT INSERTS STATES THAT CARE MUST BE TAKEN TO PREVENT CONTAMINATION OF THE SAMPLE DURING COLLECTION AND INOCULATION INTO THE BD BACTEC¿ VIAL. PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSED SEPTUM, OR LEAKAGE. DO NOT USE ANY VIAL SHOWING EVIDENCE OF CONTAMINATION. A CONTAMINATED VIAL COULD CONTAIN POSITIVE PRESSURE. IF A CONTAMINATED VIAL IS USED FOR DIRECT DRAW, GAS OR CONTAMINATED CULTURE MEDIA COULD BE REFLUXED INTO THE PATIENT¿S VEIN. VIAL CONTAMINATION MAY NOT BE READILY APPARENT. PRIOR TO USE, THE USER SHOULD EXAMINE THE VIALS FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS THAT ARE CRACKED OR LEAKING, OR DISPLAY 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.

    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 WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN AN UNSPECIFIED NUMBER OF SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION IDENTIFIED AS YEAST SEEN IN TEN SAMPLES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65072 BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5182381 30382904420223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown