BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 18GAX1.16IN PRN SLM NPVC

    MDR report key: 21798868 · Received April 8, 2025

    Report

    Report Number
    3006948883-2025-00057
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 22, 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#4171135): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN JUL, 2024, AND PACKAGED AT CFS PACKAGE LINE IN JUL, 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND . 4. POSSIBLE CAUSES: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 18GAX1.16IN PRN SLM NPVC LEAKED THE NURSE FOUND FLUID AND BLOOD LEAKAGE AT THE END OF THE INDWELLING NEEDLE DURING THE PATIENT'S CT EXAMINATION, WHICH WAS PROMPTLY DETECTED AND TREATED WITHOUT FURTHER ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721464 BD INTIMA-II 18GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown