BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20563416 · Received October 29, 2024

    Report

    Report Number
    3002601200-2024-00562
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 26, 2024
    Report Date
    November 4, 2024
    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. DHR/BHR REVIEW LOT#4081458 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE ABNORMAL STATES OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE CANNOT 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 PROVIDED.

    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. AFTER PLACING AN INTRAVENOUS NEEDLE INTO THE PATIENT AND CONNECTING THE INFUSION SET, IT WAS FOUND THAT FLUID WAS LEAKING OUT OF THE CONNECTION, AND AFTER REPLACING THE CONNECTOR AND REPEATEDLY CONNECTING IT, IT WAS FOUND THAT FLUID WAS STILL LEAKING OUT FROM THE CONNECTOR PIPING OF THE INTRAVENOUS NEEDLE, AND THEN THE NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168154 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown