BEUDAMED
    FDA Adverse Event Death Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 6241713 · Received January 11, 2017

    Report

    Report Number
    1820334-2017-00017
    Event Type
    Death
    Date Received
    January 11, 2017
    Report Date
    August 11, 2017
    Manufacturer
    COOK INC
    Product Code
    GAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THE DATE OF DEATH WAS DETERMINED TO BE BETWEEN (B)(6) 2006 AND (B)(6) 2008. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWING, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. IT COULD BE POSSIBLE THAT THE USER TECHNIQUE, SPECIFICALLY NOT FOLLOWING STANDARD ANTISEPTIC TECHNIQUES COULD HAVE CONTRIBUTED TO THE INFECTION. HOWEVER, DUE TO INSUFFICIENT INFORMATION ON PRODUCT AND WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE IF THIS ISSUE IS ATTRIBUTED TO A PROCEDURALLY-RELATED CIRCUMSTANCE OR DEVICE -ELATED. AS REPORTED IN THE JOURNAL ARTICLE, THE PATIENT EXPIRED FROM MULTIORGAN FAILURE BUT THE ROOT CAUSE OF THE INFECTION IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CERVINI, HESLEY, INCIDENCE OF INFECTIOUS COMPLICATIONS AFTER AN ULTRASOUND-GUIDED INTERVENTION. AJR 2010; 195:846¿850: THE ABOVE REFERENCED JOURNAL ARTICLE REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ULTRASOUND-GUIDED PARACENTESIS PROCEDURE ON AN UNSPECIFIED DATE. STERILE ABDOMINAL FLUID (ASCITES) WAS OBTAINED. THE PATIENT SUBSEQUENTLY UNDERWENT A SECOND PARACENTESIS PROCEDURE SEVEN (7) DAYS FOLLOWING THE INITIAL PROCEDURE. THE ABDOMINAL FLUID OBTAINED AT THE TIME OF THE SECOND PROCEDURE CULTURED POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT DEVELOPED PERITONITIS. THE PATIENT EXPIRED FIVE (5) DAYS FOLLOWING THE SECOND PROCEDURE. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE. THE AUTHORS STATE THAT THE PERITONITIS EVENT IS CONSIDERED PROCEDURE RELATED BECAUSE THE PATIENT HAD STERILE ASCITES AT THE TIME OF THE INITIAL PROCEDURE. THE AUTHORS SPECULATE THAT THE CAUSE OF THIS PATIENT DEATH WAS LIKELY RELATED TO THE PATIENT¿S SEVERE CLINICAL CONDITION - MULTIORGAN FAILURE IN THE SETTING OF FULMINANT LIVER FAILURE WITH HEPATORENAL SYNDROME RATHER THAN TO THE PERITONITIS THAT DEVELOPED AFTER PARACENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24925 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GAA COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death