BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 10609539 · Received September 30, 2020

    Report

    Report Number
    1820334-2020-01782
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 27, 2020
    Manufacturer
    COOK INC
    Product Code
    GCB
    UDI-DI
    00827002101005
    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 PRELIMINARY EXAMINATION OF THE RETURNED PRODUCT AND 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

    MODEL: RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896. OCCUPATION: CARDIAC INTERVENTIONAL TECHNOLOGIST. PMA/510(K) #: EXEMPT. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR A PARACENTESIS OR THORACENTESIS PROCEDURE. 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 DEVICE WAS DISCARDED AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073325 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A 13303128 00827002101005

    Patients

    Seq Age Sex Outcome Treatment
    1