BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21763271 · Received April 3, 2025

    Report

    Report Number
    3006948883-2025-00047
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 17, 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

    1. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW (LOT#4081456): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APR 2024 AND PACKAGED AT R240 & CFS PACKAGE LINE IN APR 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 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. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, THE SAMPLE TEST IS QUALIFIED, NO LEAKAGE IS FOUND. 4. LEAKAGE ON THE THIRD DAY OF CATHETERIZATION, INDICATING THAT THERE WAS NO LEAKAGE OF THE PRODUCT IN THE FIRST TWO DAYS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. LEAKAGE ON THE THIRD DAY OF CATHETERIZATION, INDICATING THAT THERE WAS NO LEAKAGE OF THE PRODUCT IN THE FIRST TWO DAYS. SINCE NO DEFECTIVE SAMPLE IS RETURNED, LEAKAGE OF THE PRODUCT CANNOT BE IDENTIFIED, SO THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TRACKING THE ISSUE.

    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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED PATIENT, SUPPORTIVE TREATMENT FOR MALIGNANCY, CONDITION REQUIRED INTRAVENOUS PUNCTURE OF AN INDWELLING NEEDLE, LEAKAGE AROUND THE INDWELLING NEEDLE ON THE WAY TO INTRAVENOUS INFUSION ON THE THIRD DAY, IMMEDIATE REPLACEMENT OF THE INDWELLING NEEDLE, NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459744 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081456 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown