BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PICC

    MDR report key: 3815626 · Received May 9, 2014

    Report

    Report Number
    1625425-2014-00016
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K920755
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EFFORT WAS MADE TO INSERT THE PICC LINE BUT IT DID NOT WORK SO IT WAS REMOVED. AN X-RAY WAS PERFORMED AND IT WAS NOTED THAT A 7 MILLIMETER PIECE OF THE LINE REMAINED IN THE INFANT. THE PICC LINE WAS SURGICALLY REMOVED. THE COMPLAINANT NOTED THAT THE REPORTED PROBLEM MAY BE DUE TO A TECHNIQUE ISSUE. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND DOCUMENTED PROCEDURES. CATHETERS ARE 100 PERCENT INSPECTED AT VARIOUS STAGES DURING THE MANUFACTURING PROCESS FOR ANY DAMAGE THAT MAY AFFECT THE PERFORMANCE OF THE PRODUCT. A PRESSURE TEST IS PERFORMED ON ALL CATHETERS DURING MANUFACTURING TO ENSURE THE CATHETERS CAN WITHSTAND THE PRESSURES AND FORCES WHEN UTILIZED WITHIN THE INSTRUCTIONS FOR USE. A CONTROL PULL TEST IS ALSO PERFORMED PER THE SPECIFICATIONS. PER THE RISK ANALYSIS, THE POTENTIAL CAUSE OF CATHETER BREAKAGE COULD BE DUE TO THE CLINICIAN EXCEEDING THE TENSILE STRENGTH OF CATHETER DURING REMOVAL LEAVING A PORTION OF THE CATHETER INSIDE OF THE PATIENT. IT IS PROBABLE THAT THE ROOT CAUSE OF THE BREAKAGE OF THE PICC LINE WAS DUE TO FAILURE TO FOLLOW THE IFU FOR PROPER CATHETER REMOVAL.

    Description of Event or Problem · 1

    PICC LINE WAS ATTEMPTED TO BE INSERTED BUT DID NOT WORK, SO IT WAS REMOVED. AN X-RAY WAS PERFORMED AND NOTED THAT A 7 MILLIMETER PIECE OF THE LINE REMAINED IN THE INFANT. THE PICC LINE WAS SURGICALLY REMOVED. NOTE: PER THE CUSTOMER, THIS COULD BE A TECHNIQUE ISSUE BUT HE WANTED US TO EVALUATE THE COMPLAINT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281098 L-CATH PICC PICC FOZ ARGON MEDICAL DEVICES, INC. 11051626

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention