BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21365490 · Received February 12, 2025

    Report

    Report Number
    3002601200-2025-00052
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    December 9, 2024
    Report Date
    March 7, 2025
    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 HAS NO RETURNED SAMPLES, BUT ONE PHOTO, WHICH SHOWS THAT IT IS INTIMA II PRODUCT, SKU IS 383033. 2. DHR/BHR REVIEW LOT#: 4198340. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN AUG 2024, AND PACKAGED AT CFS PACKAGE LINE IN AUG 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. TAKE RETAIN SAMPLES OF THIS BATCH TO PERFORM PRN TORQUE FORCE AND 45PSI LEAKAGE TEST, RESULTS BOTH MEET PRODUCT SPECIFICATION, PLEASE REFER TO ATTACHMENT FOR THE DETAIL. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED, PHOTOS ARE NOT AVAILABLE, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. PLANT WILL CONTINUE TRACKING THIS KIND OF DEFECT.

    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 ADAPTER / CONNECTOR WAS DEFECTIVE / DAMAGED AND LEAKED. THE PATIENT WAS HOSPITALIZED IN THE MIDDLE OF A HOSPITALIZATION FOR ESOPHAGEAL CANCER REQUIRING RADIOTHERAPY, WITH POOR APPETITE, SLIGHT WEAKNESS, OCCASIONAL NAUSEA AND VOMITING, REQUIRING INTRAVENOUS FLUIDS FOR SYMPTOMATIC TREATMENT. DURING THE INFUSION PERIOD, THE PATIENT WAS GIVEN A SUPERFICIAL INDWELLING NEEDLE IN HIS ARM, AND IT WAS FOUND THAT THE Y-TYPE INTERFACE OF THE INDWELLING NEEDLE AND THE HEPARIN CAP WERE NOT TIGHTLY CONNECTED AND COULD NOT BE TIGHTENED, WHICH LED TO LEAKAGE OF FLUID AND OBVIOUS VENOUS REGURGITATION, AND THE PATIENT COULD NOT HAVE A NORMAL INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845471 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4198340 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown