BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS GN 18GA X 1.16IN PRN NON-PVC

    MDR report key: 18620163 · Received January 31, 2024

    Report

    Report Number
    3002601200-2024-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 24, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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: (1) THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3132811, IS 18G AND PRODUCT CODE IS 383755, PRODUCED ON 2023/6, WITH A TOTAL OF (B)(4) 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. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. 3. THE CUSTOMER DID NOT RETURN SAMPLE AND PROVIDED A VIDEO OF THE DEFECTIVE SAMPLE. FROM THE VIDEO, IT CAN BE SEEN THAT THE LIQUID OVERFLOWED FROM THE SPLIT OF THE SEPTUM DURING USE. 4. THE HISTORY OF CUSTOMER COMPLAINTS FOR THE SAME BATCH OF PRODUCTS HAS BEEN REVIEWED, AND NO COMPLAINTS OF THE SAME DEFECTS HAVE BEEN FOUND. POSSIBLE CAUSE ANALYSIS: ACCORDING TO THE VIDEO PROVIDED BY THE CUSTOMER, THE LIQUID OVERFLOWED FROM THE SLIT OF THE SEPTUM,AND WAS CONTINUOUSLY LEAKING, SUSPECTED THAT THE SEPTUM WAS DAMAGED; BUT DUE TO THE CUSTOMER DID NOT RETURN SAMPLES,CAN NOT CONFIRM WHETHER IT WAS DAMAGE TO THE SEPTUM RAW MATERIALS OR DAMAGE CAUSED DURING THE PRODUCTION PROCESS. IN SUMMARY,DUE TO THE CUSTOMER DID NOT RETURN SAMPLES, CAN NOT CONFIRM THE SLIT STATUS OF THE SEPTUM,THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE CONFIRMED, AND THE FACTORY WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE TREND OF THE DEFECT COMPLAINT.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS GN 18GA X 1.16IN PRN NON-PVC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE HEAD NURSE IN THE OPERATING THEATRE REPORTED THAT THE PRODUCT WAS LEAKING AT THE ISOLATION PLUG AFTER PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374374 PEGASUS GN 18GA X 1.16IN PRN NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3132811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown