BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21781885 · Received April 5, 2025

    Report

    Report Number
    3006948883-2025-00054
    Event Type
    Malfunction
    Date Received
    April 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 17, 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 REVIEWLOT#(4233024): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN (B)(6) 2024 AND PACKAGED AT CFS PACKAGE LINE IN (B)(6) 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 SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR LEAKAGE TEST AND PRN REMOVAL TORQUE TEST, THE LEAKAGE TEST IS QUALIFIED, THERE IS NO LEAKAGE AT THE PRN, AND THE PRN REMOVAL TORQUE IS WITHIN THE PRODUCT SPECIFICATIONS. AT THE SAME TIME, THE VISUAL INSPECTION OF THE RETAINED SAMPLE WAS CARRIED OUT, AND NO ABNORMALITY WAS FOUND. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECT STATUS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE PRN RUPTURE AND 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 Y 22GAX1.00IN PRN EC SLM NPVC ADAPTER / CONNECTOR DEFECTIVE / DAMAGED. THE PATIENT WAS TREATED WITH A NEEDLE PUNCTURE FOR INTRAVENOUS INFUSION. AFTER THE PUNCTURE WAS SUCCESSFUL, THE JOINT OF THE HEPARIN CAP OF THE INDWELLING NEEDLE BROKE, CAUSING BLOOD LEAKAGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785382 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD SUZHOU (MDS) 4233024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown