BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTEC PLASTIC MYCOSIS IC/F MEDIUM

    MDR report key: 23452939 · Received November 3, 2025

    Report

    Report Number
    2647876-2025-00657
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420178
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CATALOG 42017 BATCH NO. 5073093 THE CUSTOMER REPORTED A VACUUM DRAW ISSUE. NEITHER PHOTOS NOR RETURNED GOODS SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER¿S EXPERIENCE WITH BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR ANY CAP DEFECT OR LEAKAGE. 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. ADDITIONALLY, FIVE RANDOMLY SELECTED SAMPLES WERE INSPECTED FOR CAP INTEGRITY, ALL YIELDING SATISFACTORY RESULTS. VACUUM DRAW TEST WAS PERFORMED TO RETENTION SAMPLES WITH SATISFACTORY RESULTS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. PRODUCT INSERT STATES THAT 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. IF A DIRECT DRAW PROCEDURE IS USED, MONITOR THE PROCESS CLOSELY TO AVOID REFLUXING MATERIALS INTO THE PATIENT. 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. ON RARE OCCASIONS, A VIAL NECK MAY BE CRACKED AND THE NECK MAY BREAK DURING REMOVAL OF THE FLIP-OFF CAP OR IN HANDLING. ALSO, ON RARE OCCASIONS A VIAL MAY NOT BE SEALED SUFFICIENTLY. IN BOTH CASES THE CONTENTS OF THE VIALS MAY LEAK OR SPILL, ESPECIALLY IF THE VIAL IS INVERTED. IF THE VIAL HAS BEEN INOCULATED, TREAT THE LEAK OR SPILL WITH CAUTION, AS PATHOGENIC ORGANISMS/AGENTS MAY BE PRESENT. BEFORE DISCARDING, STERILIZE ALL INOCULATED VIALS BY AUTOCLAVING. 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

    E.1. INITIAL REPORTER PHONE #: (B)(6). 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 BACTEC PLASTIC MYCOSIS IC/F MEDIUM PATIENT BLOOD INITIALLY FLOWED INTO THE BOTTLE. HOWEVER, THERE WAS THEN A BACKFLOW OF APPROXIMATELY 1 ML OF THE MEDIUM INTO THE PATIENT'S VEIN. THE SAMPLE WAS TAKEN FROM A PERIPHERAL VENOUS CATHETER WHILE USING A BLOOD CULTURE ADAPTER FROM SARSTEDT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BACTEC PLASTIC MYCOSIS IC/F MEDIUM PATIENT BLOOD INITIALLY FLOWED INTO THE BOTTLE. HOWEVER, THERE WAS THEN A BACKFLOW OF APPROXIMATELY 1 ML OF THE MEDIUM INTO THE PATIENT'S VEIN. THE SAMPLE WAS TAKEN FROM A PERIPHERAL VENOUS CATHETER WHILE USING A BLOOD CULTURE ADAPTER FROM SARSTEDT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480968 BACTEC PLASTIC MYCOSIS IC/F MEDIUM SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 5073093 00382904420178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown