BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC

    MDR report key: 19538991 · Received June 14, 2024

    Report

    Report Number
    3002601200-2024-00254
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 23, 2024
    Report Date
    July 2, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903837564
    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 REVIEW : 1 THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3234106, IS 18G AND PRODUCT CODE IS 383756, PRODUCED ON 2023/09, WITH A TOTAL OF 19000 PIECES IN THIS BATCH 2 INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY. 3 CHECK THE PRODUCTION RECORDS FOR THIS BATCH OF PRODUCTS THAT THERE ARE NO NONCONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES IN THE PROCESS OF THIS BATCH OF PRODUCTS. 2.THE CUSTOMER DID NOT RETURN SAMPLES OR PHOTOS; THE DEFECT STATUS CANNOT BE CONFIRMED. 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. 4. THE HISTORY OF CUSTOMER COMPLAINTS FOR THE SAME BATCH OF PRODUCTS HAS BEEN REVIEWED, THIS COMPLAINT IS THE SECOND TIME, AND THE RELEVANT COMPLAINT WAS (B)(4). IN SUMMARY, SINCE THE CUSTOMER DOES NOT HAVE SAMPLES OR PHOTOS RETURNED, THE SPECIFIC DEFECT STATUS CANNOT BE CONFIRMED. THEREFORE, THE ROOT CAUSE OF THE COMPLAINED DEFECT CANNOT BE DETERMINED. THE FACTORY WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE DEFECT COMPLAINT TREND. IN SUMMARY, THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE CONFIRMED, AND THE FACTORY WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE COMPLAINT TREND OF THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC LEAKED. AFTER PERFORMING THE PUNCTURE, THE NURSE FOUND THAT THE LIQUID WAS COMING OUT OF THE ISOLATION PLUG.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190458 BD PEGASUS GN 18GAX1.16IN PRN-CAP Y NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234106 00382903837564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown