MEDEX FOUR-WAY STOPCOCK EXTENSION

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE HAD BONDING ISSUES; BONDING COMING OFF. THE PATIENTS' ARTERIAL LINES WERE LEAKING BLOOD. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

H6: EVALUATION CODES UPDATED. DEVICE EVALUATION: ONE PHOTO WAS PROVIDED BY THE CUSTOMER. FROM THE PHOTO, IT WAS OBSERVED THAT THE TUBE WAS DETACHED FROM THE COMPONENT STOPCOCK. THROUGH ANALYSIS OF THE PHOTO, A PROBABLE CAUSE COULD NOT BE DETERMINED AS IT WAS OBSERVED THAT THE SOLVENT BONDING PROCESS WAS PRESENT ON THE TUBE. AS A RESULT OF THIS INVESTIGATION, IT WAS CONCLUDED THAT IT WAS NOT POSSIBLE TO REPLICATE THE FAILURE RELATED TO THIS COMPLAINT AND THE FAILURE MODE COULD NOT BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. A ROOT CAUSE FOR THE FAILURE MODE WAS NOT POSSIBLE TO BE DETERMINED. NO DHR REVIEW WAS ABLE TO BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.