BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20418320 · Received October 10, 2024

    Report

    Report Number
    3002601200-2024-00513
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 30, 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

    1. THE CUSTOMER RETURNED 3 PHOTOS AND (B)(4) ACTUAL SAMPLES, ALL OF WHICH ARE UNUSED. THE SKU IS 383083 AND THE BATCH CODE IS 4081458. PLEASE REFER TO THE ATTACHMENT (B)(4) FOR PHOTOS. 1-THE PHOTOS SHOW THAT THE END OF THE SEPTUM IS LEAKING BLOOD. 2-800MM SIMULATED CLINICAL LEAKAGE TEST IS PERFORMED ON (B)(4) ACTUAL SAMPLES, AND LEAKAGE AT THE END OF THE SEPTUM IS FOUND IN (B)(4) SAMPLES. PLEASE REFER TO THE ATTACHMENT (B)(4) FOR TEST REPORTS. 2. DHR/BHR REVIEW LOT#4081458 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 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-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. THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. THE RETURNED PHOTOS AND (B)(4) OF THE RETURNED SAMPLES SHOW LEAKAGE AT THE END OF THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVCI LEAKED THIS PRODUCT HAS BLOOD LEAKAGE DURING BLOOD COLLECTION WHEN THE NEEDLE CONE IS NOT PULLED OUT OF THE CAVITY SAMPLES CAN BE RETURNED WITH PHOTOS GREEN CLAIMS ARE NOT REQUIRED, COMPLAINT RESPONSE LETTER AND ACCEPTANCE LETTER ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344600 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVCI INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown