BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 20676273 · Received November 13, 2024

    Report

    Report Number
    3002601200-2024-00612
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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 HAS RETURNED 1 PHOTO AND 1 DEFECTIVE SAMPLE. 1-THE PHOTO SHOWS THAT THE END OF THE SEPTUM IS LEAKING BLOOD. 2-THE DEFECTIVE SAMPLE SHOWS THAT THE SKU IS 303012, THE BATCH CODE IS 4052076, THE SAMPLE HAS BEEN USED, AND THE PINHOLE OF THE SEPTUM IS NOT CLOSED AND LEAKING. PLEASE SEE THE ATTACHED PHOTOS. 2. DHR/BHR REVIEW LOT#4080076: 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) 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. 3. DUE TO SIMILAR COMPLAINTS RECEIVED FROM OTHER BATCHES OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE INTIMA II PROCESS. THE RETURNED PHOTO AND SAMPLE SHOW THE LEAKAGE AT 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    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKAGE AT SEPTUM WHEN THE NEEDLE CORE IS WITHDRAWN AFTER SUCCESSFUL PUNCTURE OF THIS PRODUCT, THERE IS A SITUATION WHERE THE SEPTUM LEAKS BLOOD; THE NUMBER AFFECTED IS 1, THE SAMPLE CAN BE RETURNED, AND A PHOTO IS PROVIDED; A GREEN CLAIM IS REQUIRED, A COMPLAINT RESPONSE LETTER (WITH OFFICIAL SEAL) IS REQUIRED, AND A COMPLAINT RECEIPT LETTER IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307054 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4080076 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown