BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRAINER CENTESIS CATHETER

    MDR report key: 7151437 · Received December 28, 2017

    Report

    Report Number
    2134812-2017-00111
    Event Type
    Death
    Date Received
    December 28, 2017
    Date of Event
    December 16, 2017
    Report Date
    December 18, 2017
    Manufacturer
    VASCULAR SOLUTIONS, INC
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR INVESTIGATION. MANUFACTURING RECORDS AND LABELING REVIEWED AND NO NON-CONFORMANCES ISSUED ASSOCIATED WITH THIS ISSUE. INFORMATION RECEIVED FROM SITE; THE CAUSE OF DEATH WAS NOT RELATED THAT THEY ARE AWARE OF, SPECIFICALLY TO THE CATHETER. THE CATHETER WAS NOT REMOVED DUE TO CRITICAL CONDITION OF PATIENT RELATED TO ADMISSION.

    Additional Manufacturer Narrative · 1

    COMPLAINT HISTORY RECORDS HAVE BEEN REVIEWED AND THERE WERE NO RECORDS RECEIVED BY THE SUPPLIER FOR SIMILAR OCCURRENCES. NO COMPLAINTS HAVE BEEN RECEIVED BY THIS SUPPLIER FOR THE REMAINDER OF UNITS OF THIS LOT NUMBER. SUPPLIER INVESTIGATION RESULTS: ONE SAMPLE HAS BEEN RETURNED CONSISTS OF HUB OF THE DILATOR ONLY AND THE COMPLAINT HAS BEEN CONFIRMED. CUSTOMER ALSO RETURNED 25 ADDITIONAL SAMPLES FROM THE SAME LOT AND TENSILE PULL FORCE OF THE HUB TO TUBE PASSED PULL TEST TO TUBE WITHOUT ANY ABNORMALITY. SUPPLIER IDENTIFIED POTENTIAL ROOT CAUSE AS MANUFACTURING OPERATOR ERROR AND INITIATED A CAPA TO REVIEW FOR POTENTIAL IMPROVEMENTS TO THE DILATOR HUB MOLD PROCESS. AS REPORTED BY THE SITE, THEY ARE AWARE THE CAUSE OF DEATH WAS NOT RELATED SPECIFICALLY TO THE CATHETER. THE CATHETER WAS NOT REMOVED DUE TO CRITICAL CONDITION OF PATIENT RELATED TO ADMISSION AS REPORTED.

    Description of Event or Problem · 1

    WHEN PERFORMING A PARACENTESIS PROCEDURE ON (B)(6) 2017. THEY PUT THE DRAINER INTO THE PATIENT, AND THEN PULLED THE NEEDLE OUT OF THE SHEATH/CATHETER. THEN, ATTACHED A SYRINGE AND PULLED OUT ABOUT 2 CC OF FLUID, AND THE HUB BROKE LOOSE FROM THE CATHETER WHILE THEY WERE DRAWING BACK THE FLUID INTO THE SYRINGE (THE HUB WAS ATTACHED TO THE SYRINGE, BUT THE CATHETER/SHEATH WAS STILL IN THE PATIENT). AS OF (B)(6) 2017, THE CATHETER WAS STILL IN THE PATIENT. RECEIVED A PHONE CALL ON (B)(6) 2017 TO REPORT THE PATIENT DIED. ADDITIONAL INFORMATION WAS RECEIVED DECEMBER 27, 2017; THE CAUSE OF DEATH WAS NOT RELATED THAT THEY ARE AWARE OF, SPECIFICALLY TO THE CATHETER. THE CATHETER WAS NOT REMOVED DUE TO CRITICAL CONDITION OF PATIENT RELATED TO ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931359 DRAINER CENTESIS CATHETER DRAINAGE CATHETER GCB VASCULAR SOLUTIONS, INC 8810 17137342

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death