BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 22576960 · Received July 23, 2025

    Report

    Report Number
    3006948883-2025-00326
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    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 4052076. 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. THE COMPLAINT UNIT WAS NOT RETURNED FOR OUR EVALUATION. A PHOTOGRAPH OF THE COMPLAINT UNIT WAS PROVIDED TO AID IN OUR INVESTIGATION. THE PHOTOGRAPH PROVIDED SHOWED THAT THE SEPTUM OF THE UNIT HAD FALLEN OFF. THE REPORTED NONCONFORMANCE HAS BEEN CONFIRMED. OUR QUALITY ENGINEERS NOTED THAT THIS PRODUCT (SKU 383057) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. IN LIEU OF THE COMPLAINT UNIT, FUNCTIONAL TESTING WAS PERFORMED ON A RETENTION SAMPLE FOR THIS LOT, THE RESULT OF THIS SHOWED THAT THE TESTED UNIT PERFORMED WITHIN PRODUCT SPECIFICATIONS; NO LEAKAGE WAS FOUND, AND NO ABNORMALITY WAS FOUND ON THE SEPTUM. FROM THE INFORMATION AVAILABLE, OUR QUALITY ENGINEERS ARE NOT ABLE TO IDENTIFY A DEFINITE ROOT CAUSE FOR THE REPORTED NONCONFORMANCE. WE RECOMMEND THE USE OF AN APPROPRIATE PRODUCT COMPATIBLE WITH HIGH PRESSURE INJECTION SCENARIOS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED WITH POWER INJECTOR THE HOSPITAL REPORTED THAT A WHITE ISOLATION PLUG WAS SPRAYED OUT DURING HIGH-PRESSURE INJECTION. THE QUANTITY IS 1. THE SAMPLE CANNOT BE RETURNED. PHOTOS CAN BE PROVIDED. A COMPLAINT REPLY LETTER AND A RECEIPT LETTER ARE REQUIRED. GREEN CLAIMS ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785554 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown