BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20473121 · Received October 17, 2024

    Report

    Report Number
    3002601200-2024-00525
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 13, 2024
    Report Date
    October 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

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

    Additional Manufacturer Narrative · 0

    DHR/BHR REVIEW LOT#4081458. 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 (B)(4) EACH. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. AS THE PLANT RECEIVED SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, 800MM SIMULATED CLINICAL LEAKAGE TEST WAS CONDUCTED ON THE RETAINED SAMPLES OF THIS BATCH, AND IT WAS 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. IN RESPONSE TO 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 THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED. AT 15:30 ON (B)(6) 2024, THE CHILD NEEDED AN INTRAVENOUS INFUSION OF NUTRITIONAL FLUIDS BECAUSE OF ¿1. PRETERM BIRTH AND 2. LOW BIRTH WEIGHT¿, THE NURSE USED A CLOSED INTRAVENOUS INDWELLING NEEDLE WITH A SUSPICIOUS DEVICE TO PLACE AN INTRAVENOUS CANNULA, AND FOUND THAT THE END OF THE ISOLATION PLUG WAS FILLED WITH BLOOD AFTER WITHDRAWING FROM THE SYRINGE, AND THEN CLEANED UP THE BLOOD IN THE PORT AND INTRAVENOUSLY PUSHED SALINE TO FLUSH THE CANNULA IN ORDER TO RULE OUT THE POSSIBILITY OF LEAKAGE. WHETHER THERE IS FLUID LEAKAGE FROM THE ISOLATION PLUG. BECAUSE OF THE ABNORMAL PERFORMANCE OF THE ISOLATION PLUG WITH BLOOD RETURN, IT PROVES THAT ITS TIGHTNESS IS POOR, AND IN THE PROCESS OF USING IT, THERE IS AN INCREASED RISK OF CATHETER-RELATED BLOODSTREAM INFECTIONS, SO IT WAS GIVEN TO CONTINUE TO CLOSELY OBSERVE THE SITE OF THE CHILD'S CATHETERIZATION FOR SIGNS OF INFECTION, AND FOR THE TIME BEING, NO INFECTIONS WERE FOUND, AND IT DID NOT CAUSE ANY ADVERSE CONSEQUENCES TO THE CHILD. IT IS NOW REPORTED TO THE MEDICAL CONSUMABLES SECTION, SO THAT THE MANUFACTURER CAN IDENTIFY THE PROBLEM WITH THIS BATCH OF PRODUCTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049681 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