BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20137125 · Received September 4, 2024

    Report

    Report Number
    3002601200-2024-00424
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 3, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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. THE CUSTOMER RETURNED 1 PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS BLOOD OOZING FROM THE END OF THE SEPTUM. 2. DHR/BHR REVIEW LOT#4052015 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN MAY 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. 4-THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM 3. AS THE PLANT RECEIVED SIMILAR COMPLAINTS FROM OTHER BATCHES 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. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. THE RETURNED PHOTO SHOWS 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 24GAX0.75IN PRN SLM NPVC LEAKED AT SEPTUM USED IN NICU, WHEN WITHDRAWING THE NEEDLE CORE, IT WILL BRING OUT BLOOD, THE CUSTOMER FEELS THAT THE ISOLATION PLUG IS NOT SEALED ENOUGH TO RETURN THE DEFECTIVE PRODUCT, CAN PROVIDE PICTURES, NEED TO CLAIM FOR COMPENSATION, NEED TO COMPLAIN ABOUT THE LETTER OF RESPONSE, NEED TO COMPLAIN ABOUT THE LETTER OF ACCEPTANCE. AND WOULD LIKE TO KNOW IF THE SAME BATCH OF PRODUCTS HAVE THE SAME PROBLEM, HOPE TO GIVE THE CUSTOMER MORE EXPLANATION!

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900039 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052015 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown