BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21562527 · Received March 10, 2025

    Report

    Report Number
    3002601200-2025-00111
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 25, 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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW (LOT#4081482): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APR 2024 AND PACKAGED AT R240 PACKAGE LINE IN APR 2024. WORK ORDER QUANTITY WAS (B)(4). 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. 3. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND, PLEASE SEE THE ATTACHED. 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. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. 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. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A CAR ACCIDENT RESULTING IN CONFUSION FOR 20 MINUTES, REQUIRING AN ENHANCED CT SCAN, TO BE PUNCTURED WITH AN INDWELLING NEEDLE, THE NURSE TOOK OUT THE INDWELLING NEEDLE TO THE PATIENT FOR PUNCTURE, AFTER SUCCESSFUL PUNCTURE AND PULLING OUT OF THE CORE, THE BLOOD BUBBLED OUT OF THE POSTERIOR END OF THE INDWELLING NEEDLE, TO BE IMMEDIATELY REMOVED FROM THE CLOSED VENOUS INDWELLING NEEDLE, REPLACE THE SITE, RE-PUNCTURE OF CLOSED VENOUS INDWELLING NEEDLES, REPLACED WITH NORMAL USE, AND NOTIFY THE PROVIDER. CAUSE THE PATIENT TO BE PUNCTURED TWICE AND COMFORT THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822213 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