BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20108852 · Received August 30, 2024

    Report

    Report Number
    3002601200-2024-00417
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 28, 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 2 PHOTOS AND 5 DEFECTIVE SAMPLES. 1-THE PHOTOS SHOW BLOOD OOZING FROM THE END OF THE SEPTUM. 2-THE DEFECTIVE SAMPLES SHOW THAT THERE ARE BLOOD STAINS AT THE END OF THE SEPTUM, NO SIGNS OF LEAKAGE AT THE CONNECTION BETWEEN THE SEPTUM AND THE CATHETER HUB, AND THE PINHOLE OF THE SEPTUM IS CLOSED. PLEASE SEE THE ATTACHED PHOTOS. 2. DHR/BHR REVIEW LOT#4081458 1-THIS BATCH OF PRODUCTS 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 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 PHOTOS AND RETURNED SAMPLES 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,

    Additional Manufacturer Narrative · 0

    H.3. 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 INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED AT SEPTUM. THE PRODUCT RETURNS BLOOD BACK TO THE OUTSIDE OF THE ISOLATION PLUG AFTER PUNCTURE. SAMPLES CAN BE RETURNED, PHOTOS AVAILABLE. NO GREEN CLAIMS, COMPLAINT RESPONSE LETTER AND ACCEPTANCE LETTER REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910813 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