BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC 26GA, SINGLE LUMEN

    MDR report key: 6088282 · Received November 8, 2016

    Report

    Report Number
    1625425-2016-00086
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION RECORDS WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. ONE CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER EXHIBITED BREAKAGE JUST BELOW THE NOSE OF THE OVERMOLDED PORTION OF THE CATHETER. THE TUBING AT THE AREA OF SEPARATION APPEARED TO BE FULLY FORMED UNDER MAGNIFICATION. THE EDGE OF THE CATHETER WAS FOUND TO BE FAIRLY STRAIGHT. THIS EFFECT HAS BEEN OBSERVED IN CONTROL CATHETERS WHOSE TUBING HAS BEEN SUBJECT TO EXCESS TENSILE FORCE. THEREFORE, EXCESS TENSILE (PULLING) FORCE APPLIED TO THE CATHETER IS A POTENTIAL ROOT CAUSE FOR THIS ISSUE. POTENTIAL SOURCES OF EXCESS TENSION INCLUDE IMPROPER SECUREMENT OR MAINTENANCE TECHNIQUES. OTHER POTENTIAL CONTRIBUTORS TO BREAKAGE INCLUDE ADVANCING/REMOVING THE CATHETER OR STYLET DESPITE RESISTANCE OR FLUSHING THE CATHETER WITH EXCESS FORCE (E.G. USING A SYRINGE SMALLER THAN 10 ML, FLUSHING THE CATHETER DESPITE EXPERIENCING RESISTANCE, FLUSHING THE CATHETER USING A 10 ML SYRINGE WITH EXCESS PRESSURE, ETC.) WHICH CAN WEAKEN THE CATHETER. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF BREAKAGE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO PRODUCT HAS BEEN RECEIVED RELATED TO THIS COMPLAINT. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. SHOULD THE RELATED PRODUCT BE RETURNED TO ARGON QUALITY, THIS COMPLAINT WILL BE UPDATED AS NECESSARY. ARGON WILL CONTINUE TO MONITOR FUTURE COMPLAINTS FOR INSTANCES OF A SIMILAR NATURE. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF BREAKAGE.

    Description of Event or Problem · 1

    PICC BROKE UNDER THE DRESSING WHILE INDWELLING IN THE PATIENT. NO PATIENT HARM. CUSTOMER DID NOT KNOW IF A NEW PICC OR PIV WAS PLACED AFTER THE BROKEN PICC WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739212 FIRST PICC 26GA, SINGLE LUMEN FIRST PICC FOZ ARGON MEDICAL DEVICES INC. 11125995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention