BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC 26GA, SINGLE LUMEN

    MDR report key: 6644031 · Received June 15, 2017

    Report

    Report Number
    1625425-2017-00080
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 15, 2017
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RETURNED. AN INJECTOR CAP WAS ATTACHED TO THE LUER ADAPTER, WHICH WAS NOT FULLY SEATED IN THE OVERMOLDED EXTENSION OF THE CATHETER. THERE WAS A GAP OF A FEW MILLIMETERS. THE LUER ADAPTER WAS REMOVED. THE POSTS HAD BROKEN OFF OF THE LUER ADAPTER. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. HOWEVER, BASED ON THE FACT THAT THE POSTS HAD BROKEN OFF THE LUER ADAPTER, IT IS POSSIBLE THAT THE DETACHMENT WAS CAUSED BY THE APPLICATION OF UNDUE FORCE TO THE LUER ADAPTER DURING THE ATTEMPTED REMOVAL OF THE INJECTOR CAP. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK AND FLOW TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF CATHETER DAMAGE.

    Description of Event or Problem · 1

    THE BEDSIDE NURSE WAS CHANGING THE INJECTOR CAP ATTACHED TO THE HUB OF THE PICC. THE HUB BECAME DETACHED FROM THE PICC DURING THIS INJECTION CAP CHANGE. THE NURSE PUT THE HUB BACK INTO PICC AND NOTIFIED NNP. NNP WILL EXCHANGE THIS PICC. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423935 FIRST PICC 26GA, SINGLE LUMEN FIRST PICC FOZ ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other