BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 6186526 · Received December 19, 2016

    Report

    Report Number
    1820334-2016-01541
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    August 18, 2017
    Manufacturer
    COOK INC
    Product Code
    GBX
    UDI-DI
    00827002086456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A FUHRMAN PLEURAL/PNEUMOPERICARDIUM DRAINAGE SET WAS NOT RETURNED/RECEIVED FOR AN EVALUATION; THEREFORE, A DEVICE FAILURE ANALYSIS COULD NOT BE PERFORMED. THE CUSTOMER REPORTS THAT THE CATHETERS SOMETIMES TWIST AND STAY KINKED COULD ONLY BE CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. BASED ON THE INFORMATION AVAILABLE A DEFINITIVE ROOT CAUSE FOR THIS REPORTED ISSUE COULD NOT BE ESTABLISHED. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WAS ONE NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. THIS ENTIRE LOT (4033281) HAS BEEN SHIPPED OUT TO CUSTOMERS. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT IS THE ONLY COMPLAINT RECEIVED ASSOCIATED WITH THIS PRODUCT/LOT NUMBER COMBINATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT; NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND THE WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER CAN SOMETIMES TWIST AND STAY KINKED AT THE POINT OF THE CATHETER BEING SECURED BY THE MOLNAR RETENTION DISC AND CABLE TIE. THE DEVICE WILL NO LONGER DRAIN WHEN THIS OCCURS AND REQUIRES SOMEONE TO NOTICE THE DEVICE IS NOT DRAINING AND THEN UNTWIST/UNKINK THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836551 FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET GBX CATHETER, IRRIGATION GBX COOK INC N/A 00827002086456

    Patients

    Seq Age Sex Outcome Treatment
    1