BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G SPIROL

    MDR report key: 7915495 · Received September 27, 2018

    Report

    Report Number
    1316297-2018-00010
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 26, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    PMA / PMN Number
    K981329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO EPIMED BY (B)(6) ON AUGUST 28, 2018: "ANESTHESIOLOGIST AT (B)(6) HOSPITAL (B)(6) WAS PERFORMING A TAP BLOCK YESTERDAY AND WHEN HE TRIED TO REMOVE THE STYLET FROM THE TBLOC CATHETER, HE COULD NOT PULL BACK THE STYLET AND HAD TO PERFORM THE PROCEDURE AGAIN WITH A NEW TRAY." ADDITIONAL INFORMATION REGARDING EVENT REPORTED TO EPIMED BY (B)(6) ON SEPTEMBER 13, 2018 PER EPIMED INQUIRY: "THE CATHETER WAS SHEARED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE. AS HE PULLED THE NEEDLE OUT AND MET RESISTANCE THE CATHETER SHEARED..." UPON RETURN TO EPIMED, BOTH DEVICES WERE EXAMINED. THE ACCOMPANYING FINISHING STYLET WAS RETURNED TO EPIMED OUTSIDE OF THE RETURNED CATHETER. DURING EXAMINATION, IT WAS OBSERVED THAT THE ACCOMPANYING STYLET WAS SEVERELY TWISTED. THIS TWISTING WAS IN A COIL-LIKE SHAPE. THE RETURNED CATHETER COATING WAS SHEARED APPROXIMATELY 7" FROM THE CATHETER'S DISTAL END. THE CATHETER'S INTERNAL SPRING REMAINED FULLY INTACT. THE DAMAGE TO THE CATHETER WAS INDICATIVE OF THE DEVICE BEING PULLED APART AS IT WAS JAGGED IN SHAPE AND NOT CUT CLEAN AS WOULD BE EXPECTED IF THE DEVICE WERE CUT BY A SHARP OBJECT; I.E. NEEDLE TIP. MEASUREMENT TESTING WAS CONDUCTED AND IT WAS DETERMINED THAT NONE OF THE CATHETER COATING WAS MISSING FROM THE DEVICE. IN ORDER TO ACQUIRE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, EPIMED EMAILED (B)(6) ON SEPTEMBER 14, 2018 WITH THE FOLLOWING QUESTIONS: ANY INFO ON THE NEEDLE? DID THE END-USER MANIPULATE THE CATHETER IN ANY WAY WHILE THE STYLET WAS IN PLACE? DID THE END-USER EXPERIENCE RESISTANCE REMOVING BOTH THE NEEDLE AND CATHETER AS A UNIT OR WAS THE NEEDLE REMOVED WHILE CATHETER WAS STILL IN PLACE? DID THE END-USER EXPERIENCE ANY RESISTANCE WHILE ATTEMPTING TO REMOVE THE CATHETER? DID THE END-USER ATTEMPT TO REMOVE THE NEEDLE WHILE THE STYLET WAS IN PLACE? AS OF THE DATE OF THIS REPORT, HALYARD HAS NOT RESPONDED TO THIS INQUIRY. DUE TO THE NATURE OF THE REPORTED COMPLAINT, TENSILE TESTING WAS PERFORMED USING THE CE-021 (TENSILE TESTER - TINIUS OLSEN). THE TENSILE TEST WAS PERFORMED USING THE RETURNED 20G SPIROL CATHETER. THE TENSILE TEST WAS COMPLETED, YIELDING A RESULT OF 4.29 LBF, EXCEEDING THE MINIMUM STANDARD OF 3.37LBF PER BS 6196:1989. THE DAMAGE TO BOTH THE CATHETER AND STYLET IS INDICATIVE OF THE STYLETTED CATHETER POSSIBLY BECOMING SNAGGED ON AN INTERNAL STRUCTURE AND SUBSEQUENTLY BEING PULLED WITH FORCE TO REMOVE FROM THE PATIENT. THE DAMAGE TO THE STYLET SUGGESTS THAT THE STYLETTED CATHETER MAY HAVE BEEN WRAPPED AROUND THE END-USERS FINGER OR ANOTHER OBJECT WHILE TENSION WAS BEING APPLIED TO THE STYLETTED CATHETER. COMPLAINT HISTORY WAS REVIEWED; REVEALING THIS IS THE FIRST TIME A STYLET HAS BEEN RETURNED TO EPIMED IN THE CONDITION THAT WAS OBSERVED WITH THIS STYLET. IF ADDITIONAL INFORMATION BECOMES AVAILABLE REGARDING THIS REPORTED COMPLAINT, EPIMED WILL UPDATE THE MDR.

    Description of Event or Problem · 1

    REPORTED TO EPIMED BY (B)(6) ON AUGUST 28, 2018: "ANESTHESIOLOGIST AT (B)(6) HOSPITAL (B)(6) WAS PERFORMING A TAP BLOCK YESTERDAY AND WHEN HE TRIED TO REMOVE THE STYLET FROM THE TBLOC CATHETER, HE COULD NOT PULL BACK THE STYLET AND HAD TO PERFORM THE PROCEDURE AGAIN WITH A NEW TRAY." ADDITIONAL INFORMATION REGARDING EVENT REPORTED TO EPIMED BY (B)(6) ON SEPTEMBER 13, 2018: "THE CATHETER WAS SHEARED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE. AS HE PULLED THE NEEDLE OUT AND MET RESISTANCE THE CATHETER SHEARED..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756288 20G SPIROL CATHETER BSO EPIMED INTERNATIONAL INC A-EP-098 NO LOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other