BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8831579 · Received July 26, 2019

    Report

    Report Number
    3006948883-2019-00590
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7109270. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE SUBMITTED. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. BD ENCOURAGES THE REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH ALL PEGASUS UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE THE EXTENSION TUBING BURST 3-4CM FROM THE WING AND LEAKED CONTRAST AGENT. THERE WAS ALSO A SMALL AMOUNT OF BLEEDING AT THE INJECTION SITE WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AT 10:11 A.M. ON (B)(6) 2019, IN PROCESS OF THE PATIENT UNDERWENT A LIVER-ENHANCED CT EXAMINATION, IT'S NOTICED THAT EXTENSION TUBING BURST, 3-4 CM AWAY FROM THE NEEDLE WING. THE DIAMETER OF THE EXT. TUBING SLIT IS ABOUT 1 CM CONTRAST AGENT (GD-EOB-DTPA) LEAKED FROM THE SLIT ON THE EXT. TUBING ALSO, A SMALL AMOUNT OF BLEEDING(2-5 ML) AT THE INJECTION SITE, HAS BEEN DISINFECTED FOR THE FIRST TIME TO STOP BLEEDING THE PATIENT'S CONDITION IS STABLE AND NO ADVERSE REACTIONS OCCUR CUSTOMER INDICATED THAT PRESSURE TEST HAS BEEN PERFORMED PRIOR TO USE, NO ABNORMALLY CONDITIONS NOTICED DURING THE TESTING.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE THE EXTENSION TUBING BURST 3-4CM FROM THE WING AND LEAKED CONTRAST AGENT. THERE WAS ALSO A SMALL AMOUNT OF BLEEDING AT THE INJECTION SITE WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AT 10:11 A.M. ON (B)(6) 2019, IN PROCESS OF THE PATIENT UNDERWENT A LIVER-ENHANCED CT EXAMINATION, IT'S NOTICED THAT EXTENSION TUBING BURST, 3-4 CM AWAY FROM THE NEEDLE WING. THE DIAMETER OF THE EXT. TUBING SLIT IS ABOUT 1 CM CONTRAST AGENT (GD-EOB-DTPA) LEAKED FROM THE SLIT ON THE EXT. TUBING ALSO, A SMALL AMOUNT OF BLEEDING(2-5 ML) AT THE INJECTION SITE, HAS BEEN DISINFECTED FOR THE FIRST TIME TO STOP BLEEDING THE PATIENT'S CONDITION IS STABLE AND NO ADVERSE REACTIONS OCCUR CUSTOMER INDICATED THAT PRESSURE TEST HAS BEEN PERFORMED PRIOR TO USE, NO ABNORMALLY CONDITIONS NOTICED DURING THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624176 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7109270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other