BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 8199920 · Received December 27, 2018

    Report

    Report Number
    1820334-2018-03766
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 3, 2018
    Report Date
    February 14, 2019
    Manufacturer
    COOK INC
    Product Code
    GCA
    UDI-DI
    00827002094987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED TO AID IN THE INVESTIGATION. THE USER FACILITY DID PROVIDE IMAGES OF THE COMPLAINT DEVICE, SHOWING VISIBLE FOREIGN MATTER IN THE SEALED PACKAGE WHICH CONFIRMS CUSTOMER TESTIMONY. A DOCUMENT REVIEW WAS ALSO CONDUCTED DURING THE INVESTIGATION. IT SHOULD BE NOTED THERE ARE NO RELEVANT NON-CONFORMANCES FOR LOT #8781601. AS THERE IS NO EVIDENCE OF SIMILAR RELATED NON-CONFORMANCES, THE INVESTIGATION HAS CONCLUDED THAT ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED. ADDITIONALLY A REVIEW OF COMPLAINTS FROM THE SAME LOTS AND FOUND NO OTHER REPORTED COMPLAINTS ASSOCIATED WITH THE LOTS. THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE RESULTS OF THE INVESTIGATION AND THE AVAILABLE INFORMATION, THE ROOT CAUSE CAN BE TRACED TO MANUFACTURING AND IS LIKELY A QUALITY CONTROL DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN ADDED TO THE EVENT DESCRIPTION SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: PRE-AMENDMENT. 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

    AS REPORTED, WHAT APPEARED TO BE A PIECE OF DARK HAIR WAS DISCOVERED DURING QUALITY INSPECTION BY A DISTRIBUTION CENTER INSIDE THE SEALED ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER PACKAGE . THIS DEVICE WAS DISCARDED AND DID NOT REACH FACILITY OR PATIENT. AS REPORTED, THE PRODUCT DID NOT REACH PATIENT, THEREFORE THERE WERE NO ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038913 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY GCA COOK INC N/A 8781601 00827002094987

    Patients

    Seq Age Sex Outcome Treatment
    1