BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19510820 · Received June 11, 2024

    Report

    Report Number
    3002601200-2024-00243
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    March 10, 2024
    Report Date
    June 21, 2024
    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

    1. DHR REVIEW LOT 3052736 1 THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(6) 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, AND THE SPECIFIC SITE OF THE LEAKAGE AND THE ABNORMAL STATE OF THE INDWELLING NEEDLE CANNOT BE IDENTIFIED. 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. CONCLUSION NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. AS THE ABNORMAL STATE OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP THE COMPLAINT.

    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 THE BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY ON (B)(6) 2024. DUE TO ACUTE APPENDICITIS, AND AFTER THE SURGERY, THE NURSE FOLLOWED THE DOCTOR'S INSTRUCTIONS TO GIVE THE PATIENT AN INDWELLING CLOSED INTRAVENOUS NEEDLE, AND WHEN USING IT TO GIVE THE PATIENT AN INFUSION, THERE WAS A LEAKAGE OF FLUIDS, WHICH WAS IMMEDIATELY REPLACED WITH AN INDWELLING NEEDLE, AND THE PATIENT WAS REINTRODUCED TO INTRAVENOUS PUNCTURE AND INFUSION. AFTER THE REPLACEMENT, THE INFUSION WAS NORMAL AND DID NOT CAUSE ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802669 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3052736 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown