BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 7961075 · Received October 12, 2018

    Report

    Report Number
    1820334-2018-03069
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 27, 2018
    Report Date
    January 11, 2019
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002095014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS: PRODUCT RECEIVED ON: 17OCT2018 INVESTIGATION/EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), VISUAL INSPECTION, DIMENSIONAL VERIFICATION, FUNCTIONAL TEST, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER RETURNED ONE OPENED DEVICE TO COOK FOR INVESTIGATION. THERE WAS NO SURFACE DAMAGE AND NO BOATER PRESENT ON THE DEVICE. THE TUBING AND CAP WERE SECURED TO THE HUB. A LEAK TEST WAS PERFORMED AND THE DEVICE LEAKED AT THE JUNCTION OF THE CAP AND THE TUBING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE ARE ADEQUATE CONTROLS IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCTS. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE PRODUCT AND SUBASSEMBLY LOTS, AND NO RELATED NON-CONFORMANCES WERE FOUND. IT SHOULD BE NOTED THERE HAVE BEEN NO REPORTED COMPLAINTS FOR LOT: 9130290. THERE IS NO EVIDENCE TO SUGGEST THERE ARE NON-CONFORMING DEVICES IN HOUSE OR IN FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. A QUALITY ENGINEERING RISK ASSESSMENT WAS PERFORMED AND NO FURTHER RISK REDUCTION ACTIVITIES ARE REQUIRED. COOK INCORPORATED WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND NOTIFY APPROPRIATE PERSONNEL 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 INFORMATION HAS BEEN ADDED TO THE DESCRIPTION OF THE EVENT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    OCCUPATION: PURCHASING COORDINATOR. 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 AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN THE PATIENT FOR AN UNSPECIFIED DRAINAGE PROCEDURE. AFTER THE DEVICE WAS PLACED IT IMMEDIATELY STARTED LEAKING. AN ADDITIONAL DEVICE WAS OPENED AND 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
    800631 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 9130290 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1