BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 7948130 · Received October 9, 2018

    Report

    Report Number
    1820334-2018-03004
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 18, 2018
    Report Date
    December 14, 2018
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002128767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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. ONE UNLOCKED 7.0FR MAC-LOC CATHETER WAS RETURNED FOR EVALUATION IN USED CONDITION. BIOLOGICAL MATTER WAS PRESENT ON THE DEVICE, WITH NO ADDITIONAL SURFACE DAMAGE NOTED. A LEAK TEST WAS CONDUCTED AND CONFIRMED THE PRESENCE OF A LEAK BETWEEN THE CONNECTOR CAP AND CATHETER TUBING. TUG AND TWIST TESTS REVEALED THAT THE PROXIMAL ASSEMBLY WAS SECURE, HOWEVER, THE TUBING WAS ABLE TO FREELY ROTATE WITHIN THE CAP. ATTEMPTS TO REMOVE THE CAP LEFT THE CAP DAMAGED. THE FLARE APPEARED TO BE LOPSIDED, BUT DUE TO THE COMPRESSION OF THE FLARE WITHIN THE CAP AND THE POTENTIAL FOR DAMAGE UPON REMOVAL, IT CANNOT BE DETERMINED IF THE FLARE WAS MANUFACTURED TO SPECIFICATIONS. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. HOWEVER, UPON VISUAL INSPECTION, THE NUMBER OF THREADS SHOWING ON THE ADAPTER EXCEEDED WHAT WAS DETAILED IN MANUFACTURING SPECIFICATIONS, INDICATING NONCONFORMING PRODUCT. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. BASED ON THE REVIEW OF 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 SHOWED ONE RELEVANT NONCONFORMANCE IN SUBASSEMBLY LOT SA8513117 FOR A FAILED LEAK TEST, IN WHICH THE AFFECTED DEVICE WAS SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR LOT 8854244. 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

    CATALOG #: ULT7.0-35-25-P-5S-CLDM-TONG-050399. 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 AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED FOR AN UNKNOWN DRAINAGE PROCEDURE. WHILE THE PHYSICIAN WAS DRAWING FLUID FROM THE PATIENT, A BUBBLE WAS FOUND INSIDE THE SYRINGE, INDICATING THE PRESENCE OF A LEAKAGE. MFR. REPORT: 1820334-2018-03003 RECORDS THIS FIRST LEAKAGE. THE CATHETER WAS THEN EXCHANGED FOR A NEW CATHETER OF THE SAME TYPE. A BUBBLE WAS AGAIN FOUND IN THE SYRINGE WHILE DRAINING WITH THE NEW CATHETER. THIS REPORT RECORDS THIS SECOND LEAKAGE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 22OCT2018 THAT THE DEVICE WAS PLACED IN THE PLEURA OF A PATIENT WITH SHORTNESS OF BREATH AND LUNG CANCER WITH LIVER METASTASIS DURING AN ULTRASOUND GUIDED PLEURAL DRAINAGE. DURING THE PROCEDURE, THE PHYSICIAN LOCKED THE CATHETER AND DURING ASPIRATION, ONLY GAS MIXED WITH A SMALL AMOUNT OF PLEURAL FLUID COULD BE ASPIRATED. THE CATHETER WAS THEN UNLOCKED AND RE-LOCKED WITH ADDITIONAL FORCE TO TIGHTEN THE THREAD FOR A MORE SECURE CATHETER LOCK. AS BEFORE, ONLY GAS MIXED WITH A SMALL AMOUNT OF PLEURAL FLUID COULD BE ASPIRATED. THIS PROCESS WAS REPEATED TWO TO THREE TIMES DURING THE PROCEDURE. THE GUIDE WIRE WAS THEN INSERTED TO EXCHANGE THE DEFECTIVE CATHETER WITH A DEVICE FROM ANOTHER MANUFACTURER FOR A SUCCESSFUL COMPLETION OF THE PROCEDURE. ADDITIONAL DEVICES USED DURING THE PROCEDURE INCLUDED A SYRINGE, TROCAR NEEDLE AND AN AMPLATZ GUIDE WIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787645 ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 8598084 00827002128767

    Patients

    Seq Age Sex Outcome Treatment
    1 TROCAR NEEDLESYRINGEAMPLATZ GUIDE WIRE