BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y

    MDR report key: 18538908 · Received January 18, 2024

    Report

    Report Number
    3014704491-2024-00015
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    November 15, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BD (SUZHOU)
    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 REVIEW: (1)THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3234088, IS 24G AND PRODUCT CODE IS 383912,PRODUCED ON(B)(4)2023, 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.NO SAMPLES OR PICTURES WERE RETURNED,THE DEFECT STATUS CANNOT BE CONFIRMED. 3.TAKE THE RETAINED SAMPLE OF THIS BATCH FOR SYSTEM DRAG FORCE 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. H3 OTHER TEXT : SEE NARRATIVE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y NEEDLE DISENGAGEMENT WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VENOUS ACCESS IS ESTABLISHED AND THE NEEDLE CORE IS DIFFICULT TO WITHDRAW AFTER A SUCCESSFUL PUNCTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579377 BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3234088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown