BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20677413 · Received November 13, 2024

    Report

    Report Number
    3002601200-2024-00615
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    September 25, 2024
    Report Date
    December 3, 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

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AS DESCRIBED IN THE FOLLOW-UP INFORMATION, NEITHER THE CATHETER NOR THE EXTENSION TUBING WAS DAMAGED DURING INFUSION, AND THE DEFECTIVE SAMPLE WAS DISCARDED. DHR/BHR REVIEW LOT#2053283: THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2022, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 2022. WORK ORDER QUANTITY WAS (B)(4) EACH. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 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. 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 SPECIFIC SITE AND STATES OF THE CRACK OF THE DEFECTIVE SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE CRACK CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24 GA X 0.75 INCH PRN EC SLM NPVC CATHETER DEFECTIVE DAMAGED REPLACEMENT OF INDWELLING NEEDLE FOUND TO BE CRACKED DURING INFUSION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070422 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 2053283 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown