BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 21183153 · Received January 17, 2025

    Report

    Report Number
    3002601200-2024-00828
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    October 29, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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

    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#4081482. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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 SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. NO THE SAME COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY WAS FOUND IN THE PROCESS AND RETAINED SAMPLES, AND THE SPECIFIC LEAKAGE LOCATION COULD NOT BE DETERMINED BECAUSE NO SAMPLES AND PHOTOS WERE RETURNED, SO THE ROOT CAUSE OF THE LEAKAGE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED ON (B)(6) 2024, A 20G INDWELLING NEEDLE WAS USED TO PUNCTURE A VEIN PREOPERATIVELY. AFTER SUCCESSFUL PUNCTURE, BLOOD WAS FOUND TO FLOW OUT OF THE END OF THE NEEDLE. AFTER CALMING THE PATIENT AND EXPLAINING THE SITUATION, THE NEEDLE WAS WITHDRAWN AND RE-PUNCTURED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056100 BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown