BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 21816037 · Received April 10, 2025

    Report

    Report Number
    3006948883-2025-00064
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 24, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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#4081480) : 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024 AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4). 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 (B)(4) IN PROCESS TESTING AND (B)(4) 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. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLES. THE PHOTO SHOW BLOOD FROM THE END OF THE SEPTUM. 3. PERFORMED SEPTUM LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PRODUCTION PROCESS; ALL THE TEST RESULTS WERE WITHIN THE REQUIREMENTS OF THE PRODUCT SPECIFICATIONS. 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 20GAX1.16IN PRN SLM LEAKED ON (B)(6) 2025 AT 3:50 A.M. THE NURSE PERFORMED A PUNCTURE ON A PATIENT AND WITHDREW THE CORE OF THE NEEDLE, THE END WAS NOT CLOSED AND BLOOD OOZED OUT. THIS RESULTED IN THE PATIENT BEING RE-PUNCTURED WITH AN INDWELLING NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471804 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown