BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TPN SINGLE LUMEN TPN CATHETER SET

    MDR report key: 3063361 · Received March 28, 2013

    Report

    Report Number
    1820334-2013-00146
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    December 14, 2012
    Report Date
    March 7, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE RUPTURES ARE. PER INFO SUPPLIED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED. QUALITY CONTROL PERFORMS A FINAL INSPECTION FOR THE TOTAL NUTRITION CATHETER, SINGLE LUMEN TO CONFIRM OVERALL CATHETER SURFACE IS CLEAN WITHOUT EXCESSIVE IMPERFECTIONS OR DAMAGE PRIOR TO SHIPPING. THIS PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) WHICH STATES UNDER WARNINGS / PRECAUTIONS: "IF LUMEN FLOW IS IMPEDED, DO NOT FORCE INJECTION OR WITHDRAWAL OF FLUIDS. NOTIFY THE ATTENDING PHYSICIAN IMMEDIATELY." / "SILICONE CATHETERS ARE NOT DESIGNED FOR POWER INJECTION. CATHETER RUPTURE MAY OCCUR. USE OF A 10 ML SYRINGE OR LARGER WILL REDUCE THE RISK OF CATHETER RUPTURE." WITHOUT THE COMPLAINT DEVICE RETURNED IT CANNOT BE DETERMINED WHAT MAY HAVE CAUSED THE FAILURE MODE. STEPS HAVE BEEN PREVIOUSLY TAKEN, AT MGMT DISCRETION IN AN EFFORT TO ALLEVIATE / REDUCE THE OCCURRENCE OF THIS FAILURE MODE. PER INFO SUPPLIED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED. WITHOUT THE COMPLAINT DEVICE RETURNED IT CANNOT BE DETERMINED WHAT MAY HAVE CAUSED THE FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSESSMENT WAS NOT UPDATED IN RESPONSE TO THIS COMPLAINT. HOWEVER, THE INCLUSION OF THIS COMPLAINT WOULD NOT CHANGE THE CONCLUSION.

    Description of Event or Problem · 1

    THE DEVICE USED ON A NEWBORN PT FOR INFUSION OF DRUGS AND PATERNAL NUTRITION. ON THE SIXTH DAY BEGAN TO POUR OUT NUTRITION AND AFTER EXAMINATION OF THE PEDIATRIC SURGEON FOUND THAT THERE WAS A CRACK IN THE CATHETER. ON (B)(6) 2013: CONFIRMED CATHETER WAS REPLACED. NO ADDITIONAL INFO WAS PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127364 COOK TPN SINGLE LUMEN TPN CATHETER SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA F3112664

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention