BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 10547263 · Received September 17, 2020

    Report

    Report Number
    1820334-2020-01704
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    October 27, 2020
    Manufacturer
    COOK INC
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. THERE IS NO INFORMATION CONFIRMING DEVICE MALFUNCTION OR SERIOUS INJURY. CATHETER PUNCTURE DURING NEEDLE INSERTION PRIOR TO USE HAS "LOW IMPACT" ON THE PATIENT AND DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE COMPLAINT EVENT, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENTS OCCURRED SOMETIME OVER THE LAST COUPLE MONTHS. MODEL# RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896. OCCUPATION: CARDIAC INTERVENTIONAL TECHNOLOGIST. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED YUEH CENTESIS DISPOSABLE CATHETER NEEDLE WERE REQUIRED FOR PARACENTESIS OR THORACENTESIS PROCEDURES. PRIOR TO PATIENT CONTACT, THE NEEDLE SPLIT THE TIP OF THE CATHETER. DURING ATTEMPTED REMOVAL OF THE INNER STYLET, THE NEEDLE ALSO "BACKS OUT," WHICH CAUSED THE SPLIT. THE DEVICES WERE DISCARDED AND SIMILAR DEVICES WERE USED TO COMPLETE THE PROCEDURE. THIS FAILURE HAS OCCURRED "REPEATEDLY OVER THE PAST COUPLE MONTHS." THE OPERATOR NOTED IT OCCURS MAYBE 1/3 OR 1/5 OF THE TIME THEY TRY TO USE THE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013626 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1