BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GA X 1.16IN PRN NON-PVC

    MDR report key: 18624260 · Received February 1, 2024

    Report

    Report Number
    3002601200-2024-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    November 19, 2023
    Report Date
    April 5, 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

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

    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 2023/06, WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; (2) CHECK THE PROCESS INSPECTION AND DELIVERY INSPECTION REPORT. THE TEST RESULTS ALL MEET THE PRODUCT STANDARDS AND THERE ARE NO ABNORMALITIES; (3) CHECK THE PRODUCTION RECORDS, THERE WERE NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2.THE CUSTOMER DID NOT RETURN SAMPLES OR PICTURES,THE DEFECT STATUS CANNOT BE CONFIRMED. 3.TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1. 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. IN SUMMARY,DUE TO THE LACK OF SAMPLES RETURNED BY THE CUSTOMER, THE SPECIFIC DEFECT STATUS CANNOT BE CONFIRMED, THEREFORE THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE FACTORY WILL CONTINUE TO MONITOR THE TREND OF THE DEFECT COMPLAINT.

    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: LEAKAGE FROM XINMA INDWELLING NEEDLES IN THE CT ROOM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073204 BD 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