BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA

    MDR report key: 21562207 · Received March 10, 2025

    Report

    Report Number
    3002601200-2025-00109
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 13, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2062110. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALTHOUGH THE REPORTED DAMAGE TO THE EXTENSION TUBING WAS CONFIRMED, THE PHOTOGRAPHS PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY A DEFINITE ROOT CAUSE. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY AND ENCOURAGE THE SUBMISSION OF ANY PHYSICAL SAMPLES YOU HAVE AVAILABLE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA TUBING WAS DEFECTIVE/DAMAGED BLEEDING FROM THE PIPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452174 BD SAF-T-INTIMA INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 2062110 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown