BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC

    MDR report key: 18530263 · Received January 17, 2024

    Report

    Report Number
    3014704491-2024-00011
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 20, 2023
    Report Date
    March 11, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    382903837182
    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

    DHR/BHR REVIEW: THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3170893, IS 24G AND PRODUCT CODE IS 383718, PRODUCED ON 2023/07, WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY. 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. THE CUSTOMER DID NOT RETURN ANY SAMPLES OR PHOTOS ,CANNOT CONFIRM THE SPECIFIC DEFECT STATUS. TAKE THE RETAINED SAMPLES 28PCS DO THE PACKAGING APPEARANCE INSPECTION, AND NO ABNORMALITIES WERE FOUND. THE INSPECTION REPORT IS ATTACHED AS ATTACHMENT 1. 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, THE CUSTOMER DID NOT RETURN ANY SAMPLES OR PHOTOS, CAN NOT CONFIRM THE SPECIFIC DEFECT OF THE PRODUCT, 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 YEL 24GAX0.75IN QSYTE-CAPY NOPVC HAD PACKAGING DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: USED IN THE DEPARTMENT FOR INTRAVENOUS INFUSION, DRUG ADMINISTRATION AND TAKING BLOOD SAMPLES, THE PACKAGING WAS FOUND TO BE BROKEN AND NOT IN COMPLIANCE WITH ASEPTIC OPERATION AT THE TIME OF USE, AND THE HOSPITAL'S STOREKEEPER WAS CONTACTED TO REPLACE IT WITH A NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667438 BD PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3170893 382903837182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown