BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 22360978 · Received June 30, 2025

    Report

    Report Number
    3006948883-2025-00250
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 1, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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. THE CUSTOMER RETURNED 1 PHOTO, NO DEFECTIVE SAMPLE. THE PHOTO SHOW THAT THE CATHETER HUB OUTSIDE THE METAL WEDGE OF THE SAMPLE IS CRACKED. 2. PRODUCTION RECORD CHECK (LOT#4243811): 1) THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 2 IN SEP 2024, AND PACKAGED IN R240 PACKAGING LINE IN SEP 2024, WITH A WORK ORDER QUANTITY OF (B)(4) PIECES. 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. 3. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, THE TEST IS PASSED, NO LEAKAGE IS FOUND ON THE SAMPLE. 4. THIS DEFECT MAY INVOLVE THE RAW MATERIAL (METAL WEDGE, CATHETER HUB) AND THE CATHETER HUB SWAGING PROCESS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS THAT THE CATHETER HUB OUTSIDE THE METAL WEDGE IS CRACKED, BUT AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM LEAKED THE PATIENT WAS GIVEN AN INDWELLING NEEDLE FOR FLUIDS IN THE EVENING, AND WHEN IT WAS PUT ON THERE WAS OOZING OF BLOOD AT THE UPPER END OF THE NEEDLE HANDLE, AND THERE WAS OOZING OF FLUID WHEN THE FLUID WAS OPENED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929079 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4243811 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown