BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA II

    MDR report key: 24783442 · Received April 3, 2026

    Report

    Report Number
    3006948883-2026-00247
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    December 17, 2025
    Report Date
    April 10, 2026
    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

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

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW (LOT#5108403): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2025 AND PACKAGED AT R240 PACKAGE LINE IN MAY 2025. WORK ORDER QUANTITY WAS (B)(4). 2) REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3) REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4) THE EXTENSION TUBING BATCHES USED IN THIS BATCH OF PRODUCTS ARE 5080026 AND 4358977. REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED ONE VIDEO BUT DID NOT RETURN THE COMPLAINT UNIT. THE VIDEO SHOWS LIQUID SEEPING OUT OF THE EXTENSION TUBE, BUT THE DAMAGE CONDITION OF THE EXTENSION TUBE CANNOT BE IDENTIFIED. 3. LEAKAGE TEST A RETAINED SAMPLE OF THIS BATCH, THE TEST QUALIFIED, NO LEAKAGE WAS OBSERVED AT THE EXTENSION TUBING. 4. CAUSE ANALYSIS: 1) DURING THE PRODUCTION AND ASSEMBLY PROCESS, ASSEMBLY GRIPPING JAW WEAR OR POOR ALIGNMENT MAY CAUSE DAMAGE TO THE EXTENSION TUBING IN THIS PART, RESULTING IN LEAKAGE. 2) WHEN THE EXTENSION TUBING IS PINCHED TO ONE SIDE AND NOT CENTERED IN THE PINCH CLAMP, THE EXTENSION TUBING MAY BE DAMAGED, RESULTING IN LEAKAGE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED VIDEO SHOWS LEAKAGE AT THE EXTENSION TUBING. THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED, AS NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND THE COMPLAINT UNIT WAS NOT RECEIVED FOR EXAMINATION. THE PLANT WILL CONTINUE TO MONITOR THIS TYPE OF DEFECT.

    Description of Event or Problem · 0

    ON THE MORNING OF (B)(6) 2025, THE NURSE PUNCTURED THE PATIENT'S CANNULA ACCORDING TO THE ROUTINE OPERATION, FIXED PROPERLY AND THEN CONNECTED TO THE FLUID FOUND THAT THE FLUID LEAKING FROM THE HOSE, SO HE GAVE THE PATIENT A GOOD EXPLANATION TO CALM DOWN, AND WAS REMOVED FROM THE NEEDLE, REPLACED WITH A QUALIFIED CANNULA TO RE-POSITION THE TUBE, THE INFUSION OF FLUIDS WENT SMOOTHLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836172 INTIMA II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 5108403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown