BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL

    MDR report key: 18194553 · Received November 22, 2023

    Report

    Report Number
    3014704491-2023-00750
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 28, 2023
    Report Date
    January 9, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903837182
    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: (1)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; (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; THE CUSTOMER DID NOT RETURN SAMPLES AND ONLY PROVIDED A PHOTO OF THE DEFECTIVE SAMPLE, WHICH HAS BEEN USED. FROM THE PHOTO, IT CAN BE SEEN THAT THE NEEDLE CORE HAS NOT BEEN COMPLETELY WITHDRAWN, AND THERE WAS LEAKAGE AT TWO LOCATIONS ON THE CATHETER. HOWEVER, THE SPECIFIC SITUATION OF THE CATHETER DAMAGE CANNOT BE CONFIRMED; TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO 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. CAUSE ANALYSIS: ACCORDING TO CUSTOMER FEEDBACK, DURING THE ROUTINE VENTING BEFORE PUNCTURING THE INDWELLING NEEDLE, THE NEEDLE COVER WAS NOT REMOVED AND NO ABNORMALITIES WERE FOUND; AFTER PUNCTURED, FOUND THAT BLOOD WAS LEAKING OUT OF THE CATHETER DURING THE RETURN OF BLOOD. IT SHOWS THAT THE PRODUCT WAS IN GOOD CONDITION BEFORE USE, AND IT IS SUSPECTED THAT DURING THE PUNCTURE PROCESS, THERE WAS A REGRESSION PHENOMENON AND A SECOND PUNCTURE, WHICH CAUSED THE NEEDLE TO PUNCTURE THE CATHETER AND CAUSE LEAKAGE. IN SUMMARY, NO ABNORMALITIES WERE FOUND DURING THE PROCESS. BASED ON CUSTOMER FEEDBACK, IT IS SUSPECTED THAT THE PRODUCT MAY HAVE BEEN PUNCTURED BY A NEEDLE DURING USE, RESULTING IN CATHETER LEAKAGE. AS THE PRODUCT HAS ALREADY BEEN USED, IT CANNOT BE CONFIRMED THAT THE COMPLAINT IS RELATED TO PRODUCT QUALITY. THE FACTORY WILL CONTINUE TO MONITOR AND MONITOR THE TREND OF THIS 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 LEAKED AT THE CATHETER JUNCTION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THERE WAS A LEAKAGE ON THE SIDE OF THE 24GY CATHETER: THE CUSTOMER PERFORMED ROUTINE VENTING BEFORE PUNCTURING THE INDWELLING NEEDLE, DID NOT REMOVE THE NEEDLE CAP, AND NO ABNORMALITY WAS FOUND. THE PUNCTURE WAS THEN PERFORMED, AND WHEN THE BLOOD WAS RETURNED, IT WAS FOUND THAT BLOOD WAS GUSHING FROM THE SIDE OF THE CATHETER, AND THEN THE INDWELLING NEEDLE WAS REMOVED, AND THE PRE-FILLED EXHAUST WAS CONNECTED OUTSIDE THE PATIENT'S BODY, AND 2 LEAKAGE SPOTS WERE FOUND ON THE SIDE OF THE CATHETER, AND THE SAMPLE WAS SUBSEQUENTLY DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989301 BD PEGASUS YEL INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3170893 00382903837182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown