BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 10410743 · Received August 14, 2020

    Report

    Report Number
    3007795799-2020-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    June 17, 2020
    Report Date
    August 14, 2020
    Manufacturer
    INTERRAD MEDICAL
    Product Code
    OKC
    PMA / PMN Number
    K180994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECURACATH DEVICE AND/OR CATHETER INVOLVED WERE NOT RETURNED FOR EVALUATION. EXTENSIVE ENGINEERING EVALUATIONS AND DESIGN VERIFICATION TESTING HAVE SHOWN THAT THE SECURACATH DEVICE IS EFFECTIVE AT HOLDING A BARD POWERPICC 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 BE 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. ANALYSES OF CATHETER LEAKS REPORTED TO INTERRAD MEDICAL AND TO THE FDA (B)(4) DATABASE HAVE BEEN PERFORMED SINCE SECURACATH HAS BEEN ON THE MARKET. THESE ANALYSES HAVE REPEATEDLY CONCLUDED THAT LEAKS OCCUR IN CATHETERS WITH AND WITHOUT THE USE OF SECURACATH, LEAKS OCCUR INTERNALLY AND EXTERNALLY TO THE PATIENT, AND LEAKS DO NOT ONLY OCCUR WITHIN THE SECURACATH WHEN USING THE SECURACATH DEVICE, THEY ALSO OCCUR DISTALLY AND PROXIMALLY TO THE DEVICE. CATHETER LEAKS THAT OCCUR WHEN THE SECURACATH DEVICE IS USED ARE NOT CONSISTENTLY LOCATED AND THESE ANALYSES FOUND NO EVIDENCE THAT THE USE OF THE SECURACATH ON CATHETERS RESULTS IN AN INCREASE IN CATHETER LEAKS. A RECENT SEARCH FROM (B)(6) 2019 THROUGH (B)(6) 2019 FOUND 83 REPORTS OF LEAKING BARD CATHETERS (EXCLUDING ANY INVOLVING THE EXTENSION TUBES/CONNECTORS). OF THOSE, 73 CASES DID NOT IDENTIFY SECURACATH. THE 83 CASES OCCURRED IN MULTIPLE PLACES ALONG THE CATHETER BOTH DISTAL AND PROXIMAL TO THE INSERTION SITE. OF THE 10 INVOLVING SECURACATH, THE FAILURES APPEAR TO HAVE BEEN PROXIMAL (4), DISTAL (2), NEAR SECURACATH (2), AND UNSPECIFIED (2) IN REGARDS TO THE SECURACATH DEVICE LOCATION. EVALUATIONS OF RETURNED CATHETERS WITH LEAKS TO INTERRAD MEDICAL HAVE REPEATEDLY FOUND CATHETER MATERIAL SURFACE ANOMALIES, WALL THICKNESS VARIATIONS, WALL SHAPE VARIATIONS, AND CATHETER EXTRUSION DEFECTS. GIVEN THE CONSISTENT REPORTS OVER THE YEARS OF CATHETERS LEAKING WITHOUT THE USE OF SECURACATH AND REPORTS OF LEAKS WHEN THE SECURACATH IS USED BEING EXTREMELY LOW, THE ROOT CAUSE OF CATHETER LEAKS, APPEAR TO BE DIRECTLY RELATED TO CATHETER CONSTRUCTION. WITH A CATHETER FROM THE SAME MANUFACTURING LOT, AT THE SAME HOSPITAL, NOT USING A SECURACATH FOR SECUREMENT ALSO DEVELOPING A LEAK, FURTHER SUPPORTS THE CONCLUSION THAT THIS IS RELATED TO CATHETER CONSTRUCTION. THERE HAVE BEEN NO MANUFACTURING OR DESIGN CHANGES TO THE SECURACATH DEVICE WITHIN THE LAST 24 MONTHS. 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

    A TRIPLE LUMEN BARD POWERPICC HF WAS PLACED ON JUNE 11TH AND SECURED WITH A 5F SECURACATH PLACED IN THE RIGHT UPPER ARM WITH 3CM OF CATHETER EXTERNAL. ON JUNE 17TH THE CATHETER WAS FOUND TO BE LEAKING INSIDE THE SECURACATH. NO DRESSING CHANGES HAD OCCURRED AND NO FLOW ISSUES WERE REPORTED. THE CATHETER WAS REPLACED WITHOUT INCIDENT. THE HOSPITAL ALSO REPORTED THAT ANOTHER CATHETER FROM THE SAME MANUFACTURING LOT THAT WAS NOT USING A SECURACATH FOR SECUREMENT ALSO DEVELOPED A LEAKED A MONTH EARLIER. THE VOLUNTARY MEDWATCH USER FACILITY REPORT NUMBER PROVIDED WAS MW509487.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871509 SECURACATH SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE OKC INTERRAD MEDICAL SCR-01

    Patients

    Seq Age Sex Outcome Treatment
    1