BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 21011446 · Received December 24, 2024

    Report

    Report Number
    3002601200-2024-00763
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 30, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 ACTUAL SAMPLES, THE SKU IS 303064, AND BATCH CODE IS 4081469. 1. 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45PSI LEAKAGE TEST ARE PERFORMED ON THE SAMPLES, THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE SEPTUMS, THE PINHOLES OF THE SEPTUMS ARE CLOSED, AND THE SEPTUMS ARE NOT DISPLACED. 2. DHR/BHR REVIEW LOT#: 4081469. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2024, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) PCS. 2. THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3. THE LEAKAGE TEST RESULTS OF 400 PCS IN PROCESS TESTING AND 32 PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS. 4. NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS. 5. THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST AND 45 PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE SEPTUMS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED BECAUSE NO LEAKAGE AT THE SEPTUM IS FOUND IN THE RETURNED SAMPLES AND RETAINED SAMPLES AFTER RELEVANT TESTING, NO ABNORMALITY IS FOUND IN THE MANUFACTURING PROCESS, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKAGE AT SEPTUM (B)(6) HOSPITAL CT ROOM IN THE PLACEMENT OF 383064, THE ISOLATION PLUG LEAKAGE OCCURRED, AND THEN REPLACED AND RE-TUBED, BATCH NUMBER 4081469, THE CUSTOMER FEEDBACK BEFORE THE BATCH NUMBER HAS OCCURRED IN A NUMBER OF ISOLATION PLUG LEAKAGE, BUT THEY ARE SELF-TREATMENT.

    Description of Event or Problem · 0

    CUSTOMER PROVIDED FOLLOWING FEEDBACK: "NO DAMAGE WAS FOUND DURING USE, IT HAS NOT BEEN REPEATEDLY PIERCED, AND NO INJECTIONS HAVE BEEN MADE WITH A SYRINGE. THE SAMPLE HAS BEEN SENT TO THE FACTORY AND HAS BEEN RECEIVED." NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511013 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown