BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 22109863 · Received May 29, 2025

    Report

    Report Number
    3006948883-2025-00160
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 3, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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#4233020): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN SEP 2024 AND PACKAGED AT R240 PACKAGE LINE IN SEP 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. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTERS ARE FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. BECAUSE THE STATE AND COMPOSITION OF THE NEEDLE CANNOT BE CONFIRMED, SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM HAD FOREIGN MATTER ON (B)(6) 2025, WHILE INTENDING TO LEAVE A 22G CLOSED IV CANNULA IN PLACE FOR A PATIENT, THE NURSE UNWRAPPED THE CLOSED IV CANNULA AND FOUND A WHITE BULGE ON THE SIDE OF THE CLOSED CANNULA TIP, MAKING IT UNUSABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709248 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4233020 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown