BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 3014277 · Received February 15, 2013

    Report

    Report Number
    1625425-2013-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE LOT NUMBER PROVIDED BY THE HOSPITAL IS NOT A VALID ARGON LOT NUMBER SO A DHR REVIEW WAS NOT POSSIBLE. THE PROBLEM DESCRIPTION WAS COMPARED TO THE INSTRUCTIONS FOR USE, QUALITY CONTROL PROCESS AND RISK MANAGEMENT DOCUMENTATION. SINCE NO SAMPLE WAS RECEIVED FOR THIS ISSUE, NO DEFINITIVE ROOT CAUSE CONCLUSIONS CAN BE DETERMINED. HISTORICALLY, THIS TYPE OF FAILURE IS DETERMINED TO BE A CARE/MAINTENANCE ISSUE. THE POTENTIAL CONTRIBUTING FACTORS ARE TAPE STRIPS PLACED OVER CATHETER TUBING, OVER PRESSURIZATION AND CATHETER "HEART" IS NOT PROPER SECURE AND UNDUE FORCE IS USED WHEN FLUSHING THE PRODUCT. IFU STATED: NEVER USE CATHETER FOR HIGH-PRESSURE INJECTION. SYRINGES SMALLER THAN 10ML AND MECHANICAL HIGH-PRESSURE INJECTORS CAN GENERATE PRESSURES CAPABLE OF RUPTURING THE CATHETER. NEVER USE FORCE TO FLUSH THE CATHETER IF RESISTANCE IS MET. NEVER PLACE TAPE STRIPS OVER THE CATHETER TUBING. THIS WILL COMPROMISE THE STRENGTH AND INTEGRITY OF THE TUBING. SINGLE LUMEN POLYURETHANE AND ALL SILICONE CATHETERS SHOULD BE SECURED WITH TAPE OR A MANUFACTURED CATHETER STABILIZATION DEVICE. THESE DEVICES SHOULD NOT BE SUTURED.

    Description of Event or Problem · 1

    ARGON 1.9FR PICC LINE BREAK RIGHT BELOW THE CIRCULAR PART THAT SAYS "ARGON", WHERE THE ACTUAL CATHETER BEGINS. THE PICC WAS PLACED AT 17:30 ON (B)(6) 2013, AND WAS DISCOVERED TO BE BROKEN AT 20:35 ON (B)(6) 2013. THE INFANT THIS PICC LINE WAS USED IN HAD NO OTHER IV'S AT THE TIME AND WAS AN EXTREMELY FRAGILE, UNSTABLE INFANT WITH VIRTUALLY ZERO VENOUS ACCESS. IT TOOK 6 HOURS FOR A NURSE PRACTITIONER TO PLACE A LOW-LYING PICC LINE TO REPLACE THIS PICC. PT WAS A MICROPREMIE THAT WAS BORN AT 24 WEEKS GESTATION. PT PASSED AWAY APPROX A WEEK AFTER OCCURRENCE. CAUSE OF DEATH: MULTI SYSTEM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69769 FIRST PICC PICC FOZ ARGON MEDICAL DEVICES INC. NA UNABLE TO CONFIRM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other