BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9FR J FEED/GASTRIC DEPR TUBE

    MDR report key: 4130382 · Received September 30, 2014

    Report

    Report Number
    9612030-2014-00057
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT COMPLIANCE. A SAMPLE WAS RECEIVED FOR EVALUATION. AFTER A VISUAL INSPECTION WAS PERFORMED ACCORDING TO PROCEDURE AND THE CATHETER TIP WAS FOUND DETACHED, THEREFORE THE FAILURE MODE REPORTED WAS CONFIRMED. THE POTENTIAL ROOT CAUSE THAT MAY CAUSE THIS CONDITION COULD BE LACK OF SOLVENT (THF) DURING THE BONDING PROCESS. SINCE THIS IS A MANUAL OPERATION THE CONDITION COULD BE ORIGINATED DUE TO A LACK OF SOLVENT (THF) BETWEEN THE TIP CONNECTOR TO THE BOLUS TIP AND HOLLOW ROD CONNECTOR. THE PRODUCTION PERSONNEL WERE NOTIFIED ABOUT THE REPORTED CONDITION. THE ACCEPTABLE QUALITY LEVEL (AQL) FOR SUB ASSEMBLY INSPECTION WAS MOVED FROM NORMAL TO A TIGHTENED FUNCTIONAL INSPECTION. A QUALITY ALERT WAS POSTED IN THE LINE TO REINFORCE THE MANUAL ASSEMBLY AND TO BRING AWARENESS TO THE OPERATORS ABOUT THE MOST CRITICAL SECTIONS THAT MUST BE COVERED WITH ENOUGH THF. TO IMPROVE THE BONDING PROCESS A NEW FIXTURE WILL BE DESIGNED TO IMPROVE AND STANDARDIZE THE THF SOLVENT APPLICATION BETWEEN THE TIP CONNECTOR TO THE BOLUS TIP AND HOLLOW ROD CONNECTOR. A NEW FIXTURE WAS PLACED IN THE ASSEMBLY LINE TO CONTROL THE LENGTH OF THE CONNECTOR. THIS ACTION WILL DETECT THE CONNECTORS THAT DO NOT MEET THE MINIMUM LENGTH. ACCORDING TO THE SAMPLE EVALUATION, THE PRODUCT WAS OVER USED AS IT WAS IN THE PATIENT FOR MORE THAN A MONTH, AND ACCORDING TO THE INSTRUCTION FOR USE REPLACE THE TUBE AT FOUR (4) WEEK INTERVALS TO ENSURE OPTIMUM TUBE PATENCY. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE. THE CUSTOMER STATES DURING USE ON A PATIENT, THE TIP OF THE CATHETER CAME OFF INSIDE THE PATIENT. THE TIP OF THE CATHETER WAS INGESTED AND THE GUIDE WIRE WAS USED TO REMOVE THE CATHETER. THE PRODUCT WAS USED MORE THAN ONE MONTH. THERE WAS NO PATIENT HARM AND NO SURGERY REQUIRED. PATIENT AGE AND GENDER NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609230 9FR J FEED/GASTRIC DEPR TUBE FEEDING TUBE KNT COVIDIEN 8884750095

    Patients

    Seq Age Sex Outcome Treatment
    1