BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8693483 · Received June 12, 2019

    Report

    Report Number
    3007795799-2019-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    February 26, 2019
    Report Date
    June 12, 2019
    Manufacturer
    INTERRAD MEDICAL
    Product Code
    OKC
    UDI-DI
    00865382000228
    PMA / PMN Number
    K180769
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019, (B)(6) MEDICAL RECEIVED A REPORT OF A 5F SECURACATH DEVICE NOT SNAPPING TOGETHER WHEN PLACED ON AN ARROW 5.5 F MIDLINE CATHETER. (B)(6) MEDICAL RECEIVED THE DEVICE INVOLVED IN THE EVENT AND PERFORMED AN EVALUATION. THE EVALUATION INCLUDED A REVIEW OF INTERNAL DOCUMENTS, PHYSICAL EXAMINATION, AND TESTING. THERE WERE NO CONCERNS IDENTIFIED WITH THE INTERNAL DOCUMENT REVIEW AND THE DEVICE WAS ABLE TO BE PLACED ONTO A 5.5F ARROW CATHETER WITHOUT ISSUE. THERE WERE NO INDICATIONS OF ANY MANUFACTURING DEFECTS, ONLY MINOR PHYSICAL DAMAGE NOTED. BASED ON THE FACT THAT BOTH COVER AND BASE OF THE SECURACATH HAD SIGNS OF MINOR PHYSICAL DAMAGE THAT IS CONSISTENT WITH PRESSING THE COVER AND BASE TOGETHER WHEN THE BASE TOWERS ARE MISALIGNED WITH THE COVER SLOTS, IT HAD TO OF OCCURRED AT THE USERS FACILITY. THIS TYPE OF MATCHING DAMAGE ON BOTH BASE AND COVER COULD NOT HAPPEN DURING THE MANUFACTURING, PACKAGING AND SHIPPING PROCESS AS THE BASE AND COVER DO NOT TOUCH UNTIL THE USER SNAPS THEM TOGETHER. IT IS ONLY AT THE USER FACILITY THAT THE COVER AND BASE COME INTO CONTACT WITH EACH OTHER. THIS WAS NOT A MALFUNCTION OF THE SECURACATH DEVICE AND NO INJURY WAS REPORTED. THIS IS BEING REPORTED TO PROVIDE A RESPONSE TO THE USER FACILITY REPORT OF A SECURACATH DEVICE MALFUNCTION (MEDWATCH REPORT #(B)(4)). THE CONCLUSION OF (B)(6) MEDICAL'S EVALUATION IS THAT THERE WAS NOT A MALFUNCTION OF THE DEVICE BUT THE CAUSE OF THE ISSUE WAS THE MISALIGNMENT OF THE BASE TOWERS WITH THE COVER SLOTS. THIS MISALIGNMENT WAS MOST LIKELY DUE TO THE CATHETER BEING OFFSET WITHIN THE GROOVE OF THE SECURACATH'S BASE. WHEN THE CATHETER IS NOT PROPERLY ALIGNED WITHIN THE GROOVE OF THE BASE, IT CAN BE DIFFICULT TO SNAP THE COVER ONTO THE BASE. THIS CAN BE AVOIDED BY MAKING SURE PER STEP 11 OF THE INSTRUCTIONS FOR USE,"ALIGN THE CATHETER WITH THE GROOVE IN THE ANCHOR BASE" BEFORE PLACING THE COVER ON.

    Description of Event or Problem · 1

    (B)(6) MEDICAL CLINICAL EDUCATOR RECEIVED A CALL ABOUT A NURSE WHO WAS PLACING A 5F SECURACATH DEVICE ON AN ARROW 5.5F MIDLINE CATHETER AND WAS UNABLE TO SNAP THE SECURACATH BASE AND COVER TOGETHER. SHE OPENED A NEW ONE THAT WORKED WITHOUT ANY PROBLEMS AND SAVED THAT DEVICE THAT DID NOT SNAP TOGETHER. THE DEVICE WAS RETURNED TO (B)(6) MEDICAL AND WAS ABLE TO BE SNAPPED ON TO A 5.5F ARROW MIDLINE CATHETER WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484218 SECURACATH SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE OKC INTERRAD MEDICAL SCR-01 A1827 00865382000228

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR