BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 33/50 SPORT W/ SLOT

    MDR report key: 4933193 · Received July 22, 2015

    Report

    Report Number
    3009211636-2015-00314
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 14, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. A SAMPLE WAS RECEIVED FOR EVALUATION. THERE WERE NO ISSUES FOUND DURING A VISUAL INSPECTION. THE SAMPLE WAS SUBMITTED TO AN UNDERWATER LEAK TEST. BUBBLES WERE DETECTED COMING FROM THE VENOUS EXTENSION LUMEN. THE ARTERIAL EXTENSION LUMEN DID NOT SHOW BUBBLES. AS PER THE INSTRUCTIONS FOR USE, IT IS NECESSARY TO PERFORM A VISUAL INSPECTION BEFORE USING THE DEVICE. DO NOT USE THE CATHETER IF IT IS CRUSHED, CRACKED, CUT OR OTHERWISE DAMAGED. CLAMPING THE CATHETER REPEATEDLY IN THE SAME SPOT COULD WEAKEN THE TUBING. EXERCISE CAUTION WHEN USING SHARP INSTRUMENTS NEAR THE CATHETER. THE CATHETER TUBING CAN TEAR WHEN SUBJECTED TO EXCESSIVE FORCE OR ROUGH EDGES. INSPECT THE CATHETER FREQUENTLY FOR NICKS, SCRAPES OR CUTS WHICH COULD IMPAIR ITS PERFORMANCE. A POSSIBLE ROOT CAUSE CAN BE DUE TO REPEATED CLAMPING OR THE CATHETER MAY HAVE COME INTO CONTACT WITH A SHARP OBJECT. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION, LEAK TESTING AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NON-CONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. AS PER PROCEDURE, MANUFACTURING PERFORMS 100% LEAK TESTING AND A 100% VISUAL INSPECTION AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. NO ADDITIONAL ACTIONS ARE REQUIRED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2015. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THE PATIENT WAS ON DIALYSIS APPROXIMATELY 5 MINUTES, BLOOD WAS NOTED ON THE GAUZE DRESSING. THERE WAS VISUAL CONFIRMATION OF A PINHOLE, LEAKING BLOOD FROM THE VENOUS LUMEN (PIGTAIL). THERE WAS NO PATIENT INJURY. THE FEMORAL CATHETER WAS EXCHANGED. THE CATHETER WAS ORIGINALLY IMPLANTED ON (B)(6) 2015. THE PATIENT CURRENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477338 PALINDROME 33/50 SPORT W/ SLOT DIALYSIS CATHETER MSD COVIDIEN 8888133500 308D39X

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR