BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 21697891 · Received March 26, 2025

    Report

    Report Number
    3006948883-2025-00018
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

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

    Additional Manufacturer Narrative · 0

    1. WE HAVE NOT RECEIVED THE DEFECT SAMPLES AND PHOTOS, AND IT IS DIFFICULT TO DETERMINE THE SPECIFIC LOCATION OF THE INDWELLING NEEDLE LEAKAGE BASED ON THE LIMITED INFORMATION. 2.PRODUCTION RECORD CHECK (LOT#4052079): 1)THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN APRIL 2024 AND PACKAGED IN CFS PACKAGING LINE IN APRIL 2024. THE NUMBER OF WORK ORDERS IS (B)(4) PIECES. 2) CHECK THE PROCESS TEST REPORT AND SHIPMENT TEST REPORT, AND THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. 3) CHECK PRODUCTION RECORDS FOR ANY CONFORMITY, DEVIATION OR REWORK BEHAVIOR. 3. THE RETAINED SAMPLES OF THIS BATCH WERE TAKEN FOR RELEVANT FUNCTIONAL TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST. ALL TESTS WERE QUALIFIED, AND NO LEAKAGE WAS FOUND IN THE SAMPLES. SEE THE ATTACHMENT FOR THE TEST REPORT. CONCLUSION: NO ABNORMALITIES WERE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND THE SPECIFIC PARTS AND ABNORMAL STATES OF THE DEFECTIVE SAMPLES COULD NOT BE IDENTIFIED, SO THE ROOT CAUSE OF LEAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. THE PATIENT WAS DIAGNOSED WITH CEREBROVASCULAR DISEASE DUE TO WEAKNESS IN THE RIGHT LIMB WITH SLURRED SPEECH FOR ONE DAY ON (B)(6) 2025 AT 9:13 AM. INFUSION TREATMENT WAS REQUIRED, AND AFTER USING THE WANLONG BD CLOSED INTRAVENOUS INDWELLING NEEDLE Y-TYPE 20G, THERE WAS BLEEDING AND OOZING, RESULTING IN A SECOND PUNCTURE OF THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694795 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown