BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIVAC KIT

    MDR report key: 12120451 · Received July 6, 2021

    Report

    Report Number
    12120451
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    PXU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SITUATION: THE TIP OF A CATHETER BROKE OFF INTO A PATIENT DURING A PERICARDIOCENTESIS. BACKGROUND: THIS IS AN ELDERLY PATIENT WHO UNDERWENT A SUCCESSFUL PERICARDIOCENTESIS ON BY THE END OF THIS MONTH. UPON WITHDRAWAL OF THE CATHETER, RESISTANCE WAS MET. INTERVENTIONS TO SAFELY REMOVE THE CATHETER TOOK PLACE. HOWEVER, THE DISTAL TIP OF THE CATHETER BROKE OFF. CT SURGERY WAS CONSULTED AND CAME TO ASSIST, ADDITIONAL ATTEMPTS TO REMOVE THE RETAINED CATHETER TIP. ASSESSMENT: DISCLOSURE TO THE PATIENT AND FAMILY OCCURRED. AN INCIDENT REPORT HAS BEEN FILED AND THE PACKAGE WITH LOT NUMBER HAS BEEN SEQUESTERED. THIS DOES NOT MEET DPH REPORTING CRITERIA AS REMOVAL OF THE CATHETER TIP WOULD LIKELY REQUIRE A STERNOTOMY AND THE RISKS OUTWEIGH THE BENEFITS. (B)(6) HOSPITAL SYSTEM WAS RECENTLY INFORMED BY BOSTON SCIENTIFIC THAT THE PERIVAC KITS STOCKED WERE BEING REPLACED DUE TO INABILITY TO OBTAIN PRODUCT FROM AN OUTSIDE VENDOR. WE BELIEVE THIS TO BE A SYSTEM ISSUE. WE HAVE RECEIVED SIMILAR COMPLAINTS FROM (B)(6) HOSPITAL AND (B)(6) HOSPITAL REGARDING THE CATHETER IN THIS KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016331 PERIVAC KIT FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS, INC. 00884450486115 T2031798

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA