BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 19538683 · Received June 14, 2024

    Report

    Report Number
    3002601200-2024-00253
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 21, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830640
    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

    DHR/BHR REVIEW LOT-3250448. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN SEPTEMBER 2023, AND PACKAGED AT CFS PACKAGE LINE IN SEPTEMBER 2023. WORK ORDER QUANTITY WAS (B)(4) EA. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR RELEVANT FUNCTIONAL TESTS: LIE DISTANCE TEST, PENETRATION FORCE TEST (INCLUDING NEEDLE TIP FORCE, CATHETER TIP FORCE AND CATHETER DRAG FORCE), BLOOD RETURN TEST, AND 45PSI LEAKAGE TEST. THE TEST RESULTS ARE ALL WITHIN PRODUCT SPECIFICATIONS. PLEASE SEE THE ATTACHED TEST REPORTS. THE OCCURRENCE OF COMPLAINTS MAY BE RELATED TO THE QUALITY OF THE PRODUCT, AND MAY ALSO BE RELATED TO THE PATIENT'S SKIN, VEIN CONDITIONS AND PUNCTURE METHOD. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE, DO NOT WITHDRAW THE NEEDLE CORE PREMATURELY, AND TO AVOID MULTIPLE PUNCTURES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSIONS: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RETURNED, THE RELEVANT TESTS CANNOT BE CARRIED OUT, AND THE ROOT CAUSE OF THE BLUNTNESS OF THE NEEDLE, THE DIFFICULTY IN BLOOD RETURNING AFTER PUNCTURE, AND THE LEAKAGE AT INSERTION SITE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THE ISSUES.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKED. CLINICAL FEEDBACK: 1. THE NEEDLES OF THIS BATCH OF PRODUCTS ARE BLUNT AND THE PATIENT FEELS STRONG PAIN; 2. IT IS DIFFICULT FOR BLOOD TO RETURN AFTER PUNCTURE; 3. IT IS EASY TO EXUDE FLUID, CAUSING REDNESS/ABSCESS ON THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373714 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3250448 00382903830640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown