BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXID 23/48 KIT W/SIDEHOLES

    MDR report key: 3853775 · Received May 30, 2014

    Report

    Report Number
    1317749-2014-00240
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS (B)(4)(JULIAN LOT NUMBER 206132X). LOT 345976 WAS RELEASED ON 03/12/12 WITH AN ORDER QUANTITY OF (B)(4) CASES. THE ASSEMBLED BENDABLE TUNNELER PART NUMBER 00420, LOT NUMBER 345464 AND LOT NUMBER 346077 WERE UTILIZED IN THE PACKAGING LOT. THE DHR REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT DURING THE PROCEDURE, THE CLINICIAN OPENED THE PRIMARY PACKAGING OF THE CATHETER ONLY TO DETECT THAT THE KIT DID NOT CONTAIN THE TUNNELING DEVICE. AS A RESULT, THE PRODUCT HAD TO BE REPLACED WITH A NEW ONE; HOWEVER, THERE WERE NONE IN STOCK IN THE PHARMACEUTICAL SERVICES UNIT. THE PROCEDURE WAS SUSPENDED WHICH EVENTUALLY RESULTED IN A PATIENT SEIZURE. THE PHYSICIAN DECIDED TO MAKE A TRANSITIONAL STEP JUGULAR CATHETER. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319905 MAXID 23/48 KIT W/SIDEHOLES DIALYSIS CATHETER MSD COVIDIEN 8888145252 206132X

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening