BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21778342 · Received April 4, 2025

    Report

    Report Number
    3006948883-2025-00052
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 15, 2025
    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

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

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW (LOT#4081482): 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) PCS. 2) THE SEPTUM INCOMING INSPECTIONS: APPEARANCE AND SIZE WERE NOT ABNORMAL, WHICH MET THE REQUIREMENTS OF INCOMING INSPECTION SPECIFICATIONS. 3) THE LEAKAGE TEST RESULTS OF 400PCS IN PROCESS TESTING AND 32PCS IN OUTGOING TESTING WERE WITHIN THE PRODUCT SPECIFICATIONS. 4) NO UNQUALIFIED, DEVIATION OR REWORK ACTIVITIES IN THE PRODUCTION PROCESS. 5) THE SEPTUM ASSEMBLY EQUIPMENT WITHOUT ABNORMAL MAINTENANCE. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. PERFORMED SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. POSSIBLE CAUSES: 1) AFTER THE NEEDLE IS PIERCED INTO THE VEIN, THERE IS BLOOD AT THE NOTCH OF THE NEEDLE. IN THE PROCESS OF NEEDLE REMOVAL, ALTHOUGH THE PERFORATION OF THE SEPTUM IS CLOSED, THE BLOOD DROPS IN THE NOTCH WILL BE BROUGHT OUT WITH THE NOTCH. IF THERE IS A LOT OF INERTIA IN THE NEEDLE REMOVAL PROCESS, BLOOD DROPS WILL BE THROWN OUT. 2) IF THE PATIENT'S ARM IS TIED TIGHT DURING THE PUNCTURE, IT WILL CAUSE GREAT PRESSURE IN THE VEIN, AND BLOOD WILL COME OUT WITH THE NEEDLE WHEN THE NEEDLE IS PULLED OUT, BUT THE SUBSEQUENT BLOOD LEAKAGE WILL NOT BE SUSTAINED. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, RELEVANT TESTS CANNOT BE PERFORMED, THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED AT SEPTUM THE PATIENT UNDERWENT AN MRI ENHANCEMENT, WHICH REQUIRED A RED INDWELLING NEEDLE. AFTER THE PUNCTURE WAS COMPLETED, THE END OF THE INDWELLING NEEDLE BLED AFTER THE NEEDLE CONE WAS WITHDRAWN, AND IT WAS NOT SEALED. AFTER THE PUNCTURE WAS DISCOVERED, IT WAS IMMEDIATELY REPLACED WITH A NEW INDWELLING NEEDLE AND RE-PUNCTURE WAS PERFORMED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001406 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown