BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 21710529 · Received March 27, 2025

    Report

    Report Number
    3006948883-2025-00029
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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.PRODUCTION RECORD CHECK (LOT#4171721): 1)THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 2 IN JULY 2024 AND PACKAGED IN R240 PACKAGING LINE IN JULY 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. 2.CUSTOMERS RETURN SAMPLES AND PHOTOS WITHOUT DEFECTS. 3.45PSI LEAKAGE TEST OF THE BATCH RETAINED SAMPLES, THE TEST PASSED, NO LEAKAGE WAS FOUND. CONCLUSION: THE ROOT CAUSE OF LEAKAGE COULD NOT BE DETERMINED BECAUSE NO ABNORMALITY WAS FOUND IN THE PROCESS AND RETAINED SAMPLES, AND THE DAMAGE STATE OF DEFECTIVE SAMPLES COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED AT ADAPTER TUBING JUNCTION (B)(6) 2025 WHILE USING AN INDWELLING NEEDLE FOR AN INFUSION FOR A PATIENT, FLUID LEAKED FROM THE HEPARIN CAP PORT OF THE INDWELLING NEEDLE, THERE WAS NO VISIBLE CRACK OR LOOSENESS AT THE HEPARIN CAP, THE PATIENT WAS IMMEDIATELY REPLACED WITH AN INDWELLING NEEDLE FOR USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358380 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171721 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown