BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 7910514 · Received September 26, 2018

    Report

    Report Number
    1820334-2018-02768
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Date of Event
    September 5, 2018
    Report Date
    December 14, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002095021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 ¿ PRODUCT RECEIVED ON: 09OCT2018 . INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A FUNCTIONAL TEST, VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER RETURNED ONE LOCKED 10.2FR MAC-LOC CATHETER IN A USED AND DAMAGED CONDITION. BIOLOGICAL MATTER WAS PRESENT ON THE DEVICE WITH NO ADDITIONAL SURFACE DAMAGE NOTED. THE DEVICE WAS COMPRISED OF THE MAC-LOC HUB, CONNECTOR CAP AND THE SUTURE STRING LEAVING THE DISTAL END OF THE CAP. NO TUBING WAS PRESENT AND REMNANT ADHESIVE WAS NOTED ON THE DEVICE. UPON REMOVAL OF THE CONNECTOR CAP, THE SUTURE STRING WAS FOUND NORMAL IN THE THREADS. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. BASED ON THE REVIEW OF THE CURRENT DOCUMENTATION, INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED AND SHOWED NO RELEVANT NONCONFORMANCES IN LOT 8863549 THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. ONE RELEVANT NONCONFORMANCE WAS FOUND IN SUBASSEMBLY LOT SA8403229 FOR A FAILED LEAK TEST ON A MAC-LOC HUB (QTY. 1), IN WHICH THE DEVICE WAS SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH LOT 8863549. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: UNKNOWN. 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 THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED INTO THE INTERCOSTAL SPACE OF A PATIENT DURING A CHEST DRAINAGE PROCEDURE ON (B)(6) 2018. FIVE DAYS LATER, IT WAS FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. UPON REMOVAL THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750204 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC NA 8487025 00827002095021

    Patients

    Seq Age Sex Outcome Treatment
    1