BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIOCENTESIS CATHETER SET

    MDR report key: 6040527 · Received October 19, 2016

    Report

    Report Number
    1820334-2016-01178
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    March 17, 2017
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002082892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, FUNCTIONAL TESTING, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED PERICARDIOCENTESIS CATHETER SET WAS RETURNED FOR INVESTIGATION. THIS SET INCLUDES ONE STOPCOCK. TUBING WAS REMOVED FROM THE STOPCOCK FOR TESTING PURPOSES. PHYSICAL EXAMINATION REVEALED ONE 3 MM CRACK AT THE BASE OF THE STOPCOCK NEXT TO THE HEX NUT. A LEAK TEST WAS PERFORMED USING FLUID FILLED SYRINGE; A FLUID LEAK WAS NOTED. THE HANDLE MANIPULATED CORRECTLY AND PIN WAS ALIGNED WITH THE HEX NUT CORRECTLY. THRU-HOLE IS OPEN. THE CAUSE OF THE CRACK AND LEAK COULD NOT BE DETERMINED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED DEVICE AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERICARDIOCENTIS DRAINAGE PROCEDURE. DURING THE PROCEDURE, BLOOD LEAKED NEAR THE STOP COCK. THE USER PLACED THE CATHETER AND ATTEMPTED TO ASPIRATE FROM THE THREE-WAY STOP COCK IN ORDER TO START THE DRAINAGE PROCESS. HOWEVER, THIS FAILED BECAUSE OF THE BLOOD LEAKAGE. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691531 PERICARDIOCENTESIS CATHETER SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 00827002082892

    Patients

    Seq Age Sex Outcome Treatment
    1