BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LUMEN INSERTION TRAY

    MDR report key: 4113251 · Received September 24, 2014

    Report

    Report Number
    3009211636-2014-00050
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COVIDIEN, COVIDIEN MANUFACTURING SOLUTIONS SA
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT SAMPLE CONSISTED OF ONE 1.9 FR DUAL LUMEN PICC ASSEMBLED CATHETER. DURING VISUAL INSPECTION, A HOLE WAS FOUND ON THE CATHETER BELOW THE BUTTERFLY. MAGNIFIED PHOTOS WERE TAKEN WHICH REVEALING A CRACK ON THE CATHETER BELOW THE BUTTERFLY WHICH IS CONSISTENT TO DAMAGE DONE MORE LIKELY WITH A SHARP OBJECT. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DEVICE HISTORY RECORD (DHR) REVIEW. AN UNDERWATER TEST WAS PERFORMED AND BUBBLES WERE DETECTED COMING OUT FROM ONE OF THE TUBING LUMENS, WHICH CORRESPONDS TO THE PRIMARY I.V EXTENSION (5 FR). THE LUMEN WHICH CORRESPONDS TO THE SECONDARY I.V EXTENSION (5 FR) DID NOT SHOW BUBBLES DURING TESTING. THE INSTRUCTIONS FOR USE STATES: DO NOT USE A SHARP CLAMP OR INSTRUMENT TO HANDLE THE CATHETER AS EVEN A MINOR CUT COULD TEAR OR BREAK THE CATHETER. IT FURTHER STATES, DO NOT STRETCH THE CATHETER, TOO MUCH TENSION COULD TEAR THE CATHETER. THE EVENT DESCRIPTION STATES THAT THE DEVICE FUNCTIONED AS INTENDED FOR TWO AND A HALF MONTHS. IT IS MORE LIKELY THAT THE DEVICE WAS DAMAGED DURING THAT TIME. THE REPORTED ISSUE HAS BEEN CONFIRMED. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS CONSIDERED MISUSE (LEAK COULD BE CAUSED DUE TO OVER BENDING, EXCESSIVE FORCE OR A SHARP OBJECT). NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING FACILITY. AS PER PROCEDURE, MANUFACTURING PERFORMS 100% LEAK TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTS A LEAK JUST BELOW THE BUTTERFLY WHERE THE CATHETER IS JOINED. ALCOHOL + PVP WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. THE PICC WAS SECURED WITH BIOPATCH. THE PICC WAS INSERTED ON (B)(6) 2014 IN THE RIGHT AC. EACH LINE WAS FLUSHED ON A REGULAR BASIS USING A 10CC SYRINGE. CHG/ALCOHOL (HUB ONLY) WAS USED TO CLEAN THE DEVICE. THE CATHETER TUBING WAS NOT BEING CLEANED. THE PICC WAS REMOVED ON (B)(6) 2014 AND REPLACED WITH ANOTHER PICC. THE STATUS OF THE PATIENT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593234 DUAL LUMEN INSERTION TRAY PERIPHERALLY INSERTED CENTRAL CATH LJS COVIDIEN, COVIDIEN MANUFACTURING SOLUTIONS SA 43311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK