BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21200019 · Received January 21, 2025

    Report

    Report Number
    3002601200-2024-00830
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 24, 2024
    Report Date
    December 31, 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. THE CUSTOMER RETURNED 3 PHOTOS, BUT DID NOT RETURN DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT BATCH CODE IS 4171642, THE SKU IS 383033, AND THERE IS LEAKAGE IN THE MIDDLE OF THE EXTENSION TUBING. 2. DHR/BHR REVIEWLOT#4171642 1 THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN JULY 2024. 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. 3. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND AT THE EXTENSION TUBING. 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): THE RETURNED PHOTOS SHOW THAT THERE IS LEAKAGE IN THE MIDDLE OF THE EXTENSION TUBING, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED BECAUSE NO ABNORMALITIES ARE FOUND IN THE PRODUCTION PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE IS RECEIVED TO IDENTIFY THE DAMAGE STATE OF THE EXTENSION TUBING. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM TUBING WAS DEFECTIVE / DAMAGED (B)(6) 2024 HEALTH CARE WORKERS CHECK THE OUTER PACKAGING IS COMPLETE, ACCESS TO THE INFUSION SET TO OPEN THE VALVE, FOUND THAT THE INDWELLING NEEDLE HOSE ON THE LIQUID LEAK OUT, IMMEDIATELY STOP USING, REPLACE THE NEW PRODUCT, DID NOT CAUSE HARM TO THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663037 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171642 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown