BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21459582 · Received February 25, 2025

    Report

    Report Number
    3002601200-2025-00075
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 6, 2025
    Report Date
    April 10, 2025
    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

    1.DHR/BHR REVIEW (LOT# 4109427): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN JUN 2024 AND PACKAGED AT R240 PACKAGE LINE IN JUN 2024. WORK ORDER QUANTITY WAS (B)(4) 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) THE CANNULA BATCH USED IN THIS BATCH OF PRODUCTS IS 4051034, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED A PHOTO AND DID NOT RETURN DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SURFACE OF THE NEEDLE IS THREADED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR APPEARANCE INSPECTION, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. BECAUSE NO RUST DEFECT WAS FOUND IN THE RETURNED PHOTOS, AND THE RETURNED SAMPLES WERE NOT RECEIVED, THE STATUS OF THE COMPLAINED SAMPLES COULD NOT BE CONFIRMED, SO THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE CONFIRMED. 5 .NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES WERE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS WERE RECEIVED FROM OTHER HOSPITALS FOR THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOWED THAT NO DEFECTS WERE FOUND. AS NO DEFECTIVE SAMPLES WERE RECEIVED FOR FURTHER TESTING AND ANALYSIS, THE ROOT CAUSE OF THE RUSTING OF THE NEEDLE CORE COULD NOT BE DETERMINED. THE FACTORY WILL CONTINUE TO MONITOR FOR SUCH DEFECTS.

    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 AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HAD RUST / CORROSION AFTER OPENING THE PACKAGE OF THE INDWELLING NEEDLE, BEFORE INJECTING THE PATIENT WITH THE INDWELLING NEEDLE TO REMOVE THE NEEDLE SHIELD CAP FOUND THAT THE NEEDLE CONE IS RUSTY, STOP USING IT, AND REPLACE IT WITH ANOTHER INDWELLING NEEDLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407034 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109427 00382903830640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown