BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20465471 · Received October 16, 2024

    Report

    Report Number
    3002601200-2024-00523
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 2, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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

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

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 2 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTOS SHOW BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4081458 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 EA. 2-REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4-THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. 3. DUE TO SIMILAR COMPLAINTS RECEIVED FROM OTHER BATCH OF PRODUCTS, THE PLANT CONDUCTED THE 800MM SIMULATED CLINICAL LEAKAGE TEST ON THE RETAINED SAMPLES OF THIS BATCH, AND FOUND THAT A FEW SAMPLES LEAKED AT THE END OF THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. THE RETURNED PHOTOS SHOW BLOOD OOZING FROM THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC BLOOD LEAKED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ¿CHRONIC VIRAL HEPATITIS B¿ AND WAS GIVEN INTRAVENOUS FLUIDS AT 8:40 A.M. ON (B)(6) 2024. THE IV NEEDLE RETURNED BLOOD WELL AFTER PUNCTURE, BUT AFTER RETRACTING THE CORE, BLOOD WAS FOUND TO BE OOZING FROM THE STOMACH AREA OF THE IV NEEDLE, WHICH POSED A RISK OF INFECTION IF IT CONTINUED TO BE USED. IN ORDER TO PREVENT INFECTION, A NEW CLOSED IV NEEDLE WAS GIVEN TO RE-PUNCTURE THE VEIN AND WAS USED NORMALLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287768 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown