BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21741393 · Received April 1, 2025

    Report

    Report Number
    3006948883-2025-00042
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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

    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#4171657): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN JULY 2024, AND PACKAGED IN 240 PACKAGING LINE IN JULY 2024, WITH (B)(4) PIECES OF WORK ORDER. 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. 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.

    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 INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED AT ADAPTER TUBING JUNCTION ON (B)(6) 2025 WHILE LANCING A PATIENT'S INDWELLING NEEDLE, OOZING WAS NOTED AT THE HEPARIN CAP CONNECTION OF A CLOSED IV INDWELLING NEEDLE, WHICH WAS IMMEDIATELY REPLACED WITH A NEW HEPARIN CAP WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010344 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171657 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown