BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20611041 · Received November 5, 2024

    Report

    Report Number
    3002601200-2024-00578
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    September 3, 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

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

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 1 PHOTO, 1 VIDEO AND 98 SAMPLES (96 OF WHICH ARE UNUSED SAMPLES AND 2 OF WHICH ARE DEFECTIVE SAMPLES, THE SKU IS 383012, AND BATCH CODE IS 4052079). 1-THE PHOTO AND VIDEO SHOW BLOOD OOZING FROM THE SEPTUM. 2-THE 800MM SIMULATED CLINICAL LEAKAGE TEST IS PERFORMED ON 96 SAMPLES, AND THE TEST RESULTS SHOW THAT NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHMENT PR#(B)(4). FOR TEST REPORTS. 3-THE 2 DEFECTIVE SAMPLES SHOW THAT THE PINHOLES AT THE END OF THE SEPTUM ARE NOT CLOSED, AND LIQUID CAN LEAK THROUGH UNCLOSED PINHOLES. PLEASE SEE THE ATTACHMENT PR#(B)(4) FOR PHOTOS. 2. DHR/BHR REVIEW LOT#4052079 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 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-AS SIMILAR COMPLAINTS RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR THE 800MM SIMULATED CLINICAL LEAKAGE TEST, AND THE SAMPLES PASS THE TEST, NO LEAKAGE IS FOUND. PLEASE SEE THE ATTACHMENT PR#(B)(4) FOR TEST REPORTS. CONCLUSION(S): THE RETURNED PHOTO, VIDEO AND 2 SAMPLES ALL SHOW THE LEAKAGE AT THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. THE PATIENT CAME TO THE HOSPITAL WITH A STROKE AND NEEDED A CRANIAL CT AT 10:30 ON (B)(6) 2024, AS PRESCRIBED BY THE DOCTOR, USING A CLOSED IV INDWELLING NEEDLE TO FACILITATE THE INFUSION OF MEDICATION, AND WHEN WITHDRAWING THE NEEDLE CORE AFTER A SUCCESSFUL PUNCTURE, HE FOUND THAT BLOOD WAS LEAKING FROM THE HOLE, AND BLOOD WAS STILL SEEPING AFTER TREATMENT, SO HE WAS GIVEN AN IMMEDIATE RE-PUNCTURE AND THE RELATED EXAMINATION WAS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71451 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052079 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown