BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 20711877 · Received November 18, 2024

    Report

    Report Number
    3002601200-2024-00623
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW LOT#4052079 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN (B)(6) 2024, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS 198,000 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. 4-AS SIMILAR COMPLAINTS RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORT. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE. IN RESPONSE TO THE LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. ON (B)(6) 2024, AFTER THE NURSE PUT THE PATIENT ON A CLOSED IV INDWELLING NEEDLE, SHE STARTED THE INFUSION AND FOUND THAT THE INDWELLING NEEDLE HOLDER WAS LEAKING, AND AFTER ATTACHING THE HEPARIN CAP THERE WAS NO LEAKAGE, AND THE PATIENT'S NORMAL INFUSION WAS COMPLETED.

    Description of Event or Problem · 0

    1. WAS THERE ANY DAMAGE SUSTAINED TO THE DEVICE DURING USE? IF SO, APPROXIMATELY WHERE? 2. WAS THE LEAKAGE OCCURRED AT THE CATHETER JUNCTION OR THE CONNECTOR? 3. PLEASE PROVIDE PICTURE / VIDEO / PHYSICAL SAMPLE IF AVAILABLE. 1. THERE IS NO DAMAGE TO THE DEVICE DURING USE 2. THE LEAK OCCURRED AT THE ISOLATION PLUG 3. NO PICTURES AND SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036945 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown