BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PICC BK W/SPLITTABLE NEEDLE

    MDR report key: 3649214 · Received February 19, 2014

    Report

    Report Number
    1625425-2014-00003
    Event Type
    Injury
    Date Received
    February 19, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 19, 2014
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND DOCUMENTED PROCEDURES. THE INSPECTION REPORTS SHOWED NO FAILURES OR INDICATIONS OF A POTENTIAL PROBLEM RELATED TO THE REPORTED BREAKAGE FAILURE. IN ADDITION, CATHETERS ARE 100 PERCENT INSPECTED AT VARIOUS STATES IN THE MANUFACTURING PROCESS. A PRESSURE TEST IS PERFORMED ON ALL CATHETERS DURING MANUFACTURING TO ENSURE THEY CAN WITHSTAND THE PRESSURE AND FORCES WHEN THE IFU IS FOLLOWED. A 28 GA L-CATH PICC CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER TUBING WAS BROKEN OFF BETWEEN THE 5-6 CM TICK MARKS. THERE WAS A KNOT AT THE 11 CM TICK MARK ON THE CATHETER TUBING. AN EXAMINATION OF THE CATHETER TUBING UNDER DIFFERENT MAGNIFICATIONS AT THE AREA OF SEPARATION SHOWED AN "UNEVEN JAGGED EDGE." THE CATHETER MAY HAVE COILED/KNOTTED DURING THE INSERTION PROCESS CAUSING A MAL-POSITIONING OF THE CATHETER. THE ROUGHNESS AROUND THE EDGES OF THE AREA OF SEPARATION IS AN INDICATION THAT UNDUE STRESS WAS PROBABLY APPLIED TO THE CATHETER. THE CATHETER MAY HAVE BEEN OVER PRESSURIZED DUE TO THE KNOT OR EXCESSIVE TENSILE STRENGTH WAS APPLIED WHEN ATTEMPTING TO REPOSITION THE CATHETER WHEN THE DRESSING WAS REMOVED. OTHER POTENTIAL ROOT CAUSES MAY BE DUE TO FAILURE TO SECURE THE CATHETER TO THE PATIENT, USE OF A SMALL VOLUME SYRINGE, AND FORCE FLUSHING WHEN RESISTANCE IS ENCOUNTERED. IT IS POSSIBLE THAT THE ROOT CAUSE OF THE COMPLAINT WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED IN THE BABY AND SECURED. AFTER THE CXR (CHEST X-RAY) WAS PERFORMED, THE LINE NEEDED TO BE ADJUSTED AND WAS PULLED BACK 1 CM. THE DRESSING WAS GENTLY REMOVED AND THE CATHETER WAS FOUND COMPLETELY BROKEN. THE BABY WAS TRANSFERRED TO THE CHM FOR EMERGENCY SURGICAL REMOVAL OF THE CATHETER FROM THE HEART. THE BABY WAS A SMALL MICRO PREMIE WITH LIMITED IV ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104207 L-CATH PICC BK W/SPLITTABLE NEEDLE L-CATH PICC FOZ ARGON MEDICAL DEVICES, INC. NA 11043766

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DA Required Intervention