BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 23923325 · Received December 30, 2025

    Report

    Report Number
    3006948883-2025-00963
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 31, 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

    INVESTIGATION RESULTS: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. BECAUSE THE SPECIFIC SITE AND ABNORMAL STATES OF THE LEAKAGE AT THE EXTENSION TUBING CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO MONITOR TO THE DEFECT.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4233779. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II 24GAX0.75IN PRN SLM LEAKED AT ADAPTER TUBING JUNCTION (B)(6) 2025, 12:00 PM DURING MICROINFUSION ADMINISTRATION VIA AN IV CATHETER PLACED IN A PEDIATRIC PATIENT, LEAKAGE OCCURRED NEAR THE CATHETER SITE. FOLLOWUP RESPONSE RECEIVED ON 25-NOV-2025 1. THE DEVICE HAS NOT BEEN DAMAGED DURING USE 2. THE DEVICE HAS BEEN USED FOR MULTIPLE PUNCTURE OPERATIONS: NO 3. WHETHER A SYRINGE HAS BEEN USED TO INJECT FLUID THROUGH THE DEVICE: NO 4. WHERE THE SPECIFIC LEAK OCCURRED: LEAKAGE FROM THE END OF THE EXTENSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001416 INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown