BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 28/48 KIT W/ SLOT

    MDR report key: 3221797 · Received July 2, 2013

    Report

    Report Number
    1317749-2013-00213
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THE PT ARRIVED AT THE HEMODIALYSIS UNIT. THE CATHETER SITE WAS OK: NO DISCHARGE, NO REDNESS. THE NURSE OPENED THE CATHETER TO CHECK PATENCY BEFORE STARTING THE TREATMENT. TO DO SO, SHE INSTALLED A 10 CC NACL 0.9% SYRINGE AT EACH ACCESS. ON THE ARTERIAL SIDE, NOTHING TO REPORT. WHEN SHE ASPIRED AND IRRIGATED THE VENOUS LINE, THERE WAS A BLOOD "OUTBURST." SHE CHECKED TO SEE IF THERE WAS ANY LEAK OR BREAKAGE IN THE CATHETER AND THERE WAS NOTHING TO REPORT. SHE THOUGHT THE SYRINGE MAY HAVE BEEN ATTACHED INCORRECTLY ON THE VENOUS LINE. THE PT HAD HIS DIALYSIS SESSION AT 4 O'CLOCK. AT THE END OF THE TREATMENT, THE NURSE INDICATES THAT THE BLUE ADAPTER COULD BE EASILY TURNED AROUND WITHIN THE TUBING. THE ATTENDING NEPHROLOGIST WAS INFORMED OF THE PROBLEM. TO CHECK FOR LEAKS, TWO HEMOSTATS WERE INSTALLED IN ADDITION TO THE CATHETER CLAMP AND THE NEPHROLOGIST ATTACHED A 10 CC NACL 0.9% SYRINGE AND PRESSED THE PLUNGER. WHEN SHE APPLIED MORE PRESSURE ON THE PLUNGER INTO THE VENOUS LINE, THE BLUE ADAPTER ATTACHED TO THE SYRINGE COMPLETELY DETACHED FROM THE CATHETER SET. THERE WAS NO PT INJURY OR ILL EFFECT. THE CATHETER WAS PULLED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301900 PALINDROME 28/48 KIT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145016 008638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK