BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8123081 · Received December 1, 2018

    Report

    Report Number
    3007795799-2018-00004
    Event Type
    Malfunction
    Date Received
    December 1, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 1, 2018
    Manufacturer
    INTERRAD MEDICAL
    Product Code
    OKC
    PMA / PMN Number
    K180769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A 4F DUAL LUMEN BARD POWERPICC SV AND 4F SECURACATH WAS SAVED AND WAS BEING SENT TO INTERRAD MEDICAL FOR EVALUATION BUT HAS YET TO BE RECEIVED AND REPORTING ACCOUNT HAS BEEN UNRESPONSIVE TO FOLLOW UP COMMUNICATIONS. THE REPORTING ACCOUNT DID PROVIDE THE SECURACATH DEVICE LOT NUMBER AND AN INVESTIGATION OF COMPONENT AND PROCESS HISTORY OF THE SECURACATH DEVICE REVEALED NO CONCERNS. AT THIS TIME THERE IS NO INFORMATION TO INDICATE THAT SECURACATH DEVICE FAILED TO MEET ITS PRODUCT SPECIFICATIONS. EXTENSIVE ENGINEERING EVALUATIONS HAVE SHOWN THAT THE SECURACATH DEVICE IS EFFECTIVE AT HOLDING A BARD POWER PICC CATHETER IN PLACE WHILE NOT NEGATIVELY IMPACTING CATHETER PERFORMANCE. TESTING ON THIS SPECIFIC TYPE CATHETER HAS BEEN DONE AND NO CONCERNS HAVE BEEN IDENTIFIED. TESTING IS DONE WITH THE SECURACATH POSITIONED AT THE "0" MARK ON REVERSE TAPERED CATHETERS TO REFLECT THE MOST CHALLENGING FOR FLOW RESTRICTION/CATHETER COMPRESSION. SPECIFIC TESTING ON BARD POWERPICC CATHETERS ATTEMPTED TO FORCE A CATHETER BREAK BY PURPOSEFULLY PINCHING THE CATHETER WITH THE BODY OF THE SECURACATH DEVICE REPEATEDLY, WHICH WOULD BE A WORST CASE SCENARIO OF INCORRECT USE OF A SECURACATH DEVICE, WITH NO CATHETER FAILURES CREATED. BASED ON PREVIOUS TESTING THIS WAS MOST LIKELY AN EXTRUSION/MATERIAL ISSUE WITH THE CATHETER AND THE CATHETER COULD HAVE FAILED WITHOUT THE USE OF SECURACATH. A SEARCH OF THE MAUDE DATABASE SHOWS 11 BARD POWERPICCS OF DIFFERENT SIZES AND TYPES HAVING REPORTED LEAKS FROM (B)(6) 2018 TO (B)(6) 2018 WITHOUT THE USE OF SECURACATH. THIS DEMONSTRATES THAT DAMAGE IS SEEN ON BARD POWERPICCS ON THE REVERSE TAPERED PORTION FROM THE HUB TO THE 7CM WITHOUT THE USE OF A SECURACATH DEVICE. IF THE SECURACATH IS PLACED PER THE IFU AND DRESSED PROPERLY AFTERWARDS, A CATHETER LEAK DURING USE IS RELATED TO CATHETER CONSTRUCTION AND NOT CAUSED BY THE SECURACATH DEVICE. THIS REPRESENTS ALL OF THE INFORMATION THAT INTERRAD MEDICAL WAS ABLE TO OBTAIN AT THIS TIME. IF ANY NEW INFORMATION COMES TO LIGHT IN THE FUTURE A FOLLOW UP REPORT WILL BE SUBMITTED TO UPDATE THIS REPORT.

    Description of Event or Problem · 1

    WHILE FLUSHING THE LINE, LEAKING NOTED UNDER THE DRESSING. LEAK APPEARED TO BE COMING FROM WITHIN THE SECURACATH DEVICE CHANNEL. WHEN DRESSING WAS TAKEN DOWN AND SECURACATH LID WAS OPENED, THE NURSE COULD SEE THERE WAS A HOLE IN THE CATHETER. CATHETER APPEARED TO BE ALIGNED CORRECTLY WITH GROOVE IN SECURACATH. NO OCCLUSION OR DIFFICULTY FLUSHING THE CATHETER PRIOR TO THE LEAKAGE STARTING. PICC LINE WAS REPLACED BY REWIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962057 SECURACATH SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE OKC INTERRAD MEDICAL SCR-01 A1825

    Patients

    Seq Age Sex Outcome Treatment
    1