BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3142069 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08512
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE CATHETER FOUND THAT DAMAGE OCCURRED TO THE CATHETER BODY AND GUIDEWIRE DURING THE IMPLANT PROCEDURE. AS RECEIVED, THE GUIDEWIRE WAS PROTRUDING FROM THE MIDDLE SET OF DISPENSING HOLES. THE EVENT INFORMATION INDICATED THAT THIS OCCURRED WHILE ATTEMPTING TO IMPLANT THE CATHETER AND WAS NOT THAT WAY WHEN THE CATHETER WAS REMOVED FROM ITS PACKAGING. THE GUIDEWIRE WAS REMOVED FROM THE CATHETER FOR DECONTAMINATION PURPOSES. AFTER THAT STEP, THE GUIDEWIRE WAS RE-INSERTED ALL THE WAY INTO THE CATHETER AND WENT ALL THE WAY TO THE END OF THE CATHETER WITHOUT PROTRUDING THROUGH ANY DISPENSING HOLES. ALSO, THERE WAS A VERY GRADUAL BEND OR ARC IN THE GUIDEWIRE FROM ITS VERY TIP TO ABOUT 13CM PROXIMAL FROM THERE. CONCLUSION: NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, LOT# H850910310, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING DIFFICULTY AT IMPLANT WITH THE CATHETER TIP MOVING RETROGRADE AND HAD TO REPOSITION THE NEEDLE. WHEN THE CATHETER WAS WITHDRAWN, THE STYLET APPEARED TO BE THROUGH THE WALL OF THE CATHETER. THE CATHETER WAS THEN REMOVED FROM THE STERILE FIELD AND A NEW CATHETER WAS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. THE DEVICE SYSTEM WAS TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244325 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR