BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 6241726 · Received January 11, 2017

    Report

    Report Number
    1820334-2017-00098
    Event Type
    Injury
    Date Received
    January 11, 2017
    Report Date
    April 5, 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

    INVESTIGATION - EVALUATION : A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE CLINICAL ASSESSMENT, IT IS FEASIBLE TO SUGGEST THE REPORTED ISSUE IS MOST LIKELY ASSOCIATED WITH PATIENT¿S CLINICAL CONDITION. IT COULD ALSO BE POSSIBLE THAT THE USER TECHNIQUE, SPECIFICALLY NOT FOLLOWING STRICT ANTISEPTIC PRACTICES COULD HAVE CONTRIBUTED TO THE INFECTION. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INTERNAL INVESTIGATION.

    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 EIGHTEEN (18) DAYS FOLLOWING THE INITIAL PROCEDURE. THE ABDOMINAL FLUID OBTAINED AT THE TIME OF THE SECOND PROCEDURE CULTURED POSITIVE FOR MULTIPLE SPECIES. THE PATIENT DEVELOPED PERITONITIS. THE PATIENTS' CONDITION REPORTEDLY IMPROVED FOLLOWING ADMINISTRATION OF UNSPECIFIED ANTIBIOTICS. 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. ADDITIONALLY, THE AUTHORS STATE THAT THIS INFECTION WAS DUE TO A POTENTIAL INADVERTENT TRANSGRESSION OF THE BOWEL BASED UPON THE CULTURE OF ENTERIC ORGANISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24444 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GAA COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention