BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21699272 · Received March 26, 2025

    Report

    Report Number
    3006948883-2025-00023
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. PRODUCTION RECORD CHECK (LOT#4233778): 1)THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 8 IN AUGUST 2024 AND PACKAGED IN R240 PACKAGING LINE AND CFS PACKAGING LINE IN MAY 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. 4.NO SIMILAR COMPLAINTS ABOUT THIS BATCH OF PRODUCTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS. 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 LEAKED AT ADAPTER TUBING JUNCTION. THE NURSE WAS ADMINISTERING INTRAVENOUS INFUSION TO THE PATIENT AT THE BEDSIDE IN THE WARD. AFTER CONNECTING THE INDWELLING NEEDLE, SHE FOUND THAT THERE WAS WATER LEAKAGE FROM THE WHITE CAP END, AND IMMEDIATELY EXPLAINED TO THE PATIENT'S FAMILY AND REPLACED THE INDWELLING NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979248 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233778 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown