BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK ECHOTIP AMNIOCENTESIS NEEDLE

    MDR report key: 7132627 · Received December 19, 2017

    Report

    Report Number
    1820334-2017-04338
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 9, 2017
    Report Date
    March 7, 2018
    Manufacturer
    COOK INC
    Product Code
    HIO
    UDI-DI
    00827002162891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE INVESTIGATION INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND SPECIFICATIONS. THE ACTUAL NEEDLES USED IN THIS COMPLAINT WERE NOT RETURNED. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF RETURNED UNUSED PRODUCT WAS CONDUCTED. THREE UNOPENED PACKAGES CONTAINING A J-DAN-201501 WERE RETURNED FOR INVESTIGATION. WITH THE ASSISTANCE OF THE SENIOR ENGINEER, RESEARCH, THE DEVICES WERE CHECKED WITH THE SONOSITE L38/10-5 ULTRASOUND PROBE/¿L38/10-5 MHZ 38MM LINEAR ARRAY TRANSDUCER. ALL THREE NEEDLES VISIBILITY WAS CLEAR AND BRIGHT IN THE ULTRASOUND. THE DEVICE HISTORY RECORD REVIEW FOUND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER 7872604. A REVIEW OF COMPLAINT HISTORY SHOWS THIS TO BE THE ONLY COMPLAINT RECEIVED ASSOCIATED WITH COMPLAINT LOT NUMBER 7872604. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED FOR THE REPORT OF ¿THE NEEDLE COULD NOT BE SEEN DURING THE AMNIOCENTESIS PROCEDURE¿. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING AN AMNIOCENTESIS PROCEDURE, THE COOK ECHO TIP AMNIOCENTESIS NEEDLE COULD NOT BE SEEN UNDER THE ULTRASOUND DURING THE PROCEDURE. ADDITIONAL INFORMATION THAT WAS RECEIVED WAS THE NEEDLE WAS MORE FLEXIBLE AND NOT VISIBLE. THERE WAS NO REPORT OF ANY ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911807 COOK ECHOTIP AMNIOCENTESIS NEEDLE HIO SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY) HIO COOK INC 00827002162891

    Patients

    Seq Age Sex Outcome Treatment
    1