ARROW THORACENTESIS KIT

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "INTRODUCER CATHETER FOLDED BACK ONTO ITSELF PREVENTING ADVANCEMENT. UPON REMOVAL THE CATHETER WAS FOUND TO BE INTACT BUT FOLDED. THERE WAS PATIENT INVOLVEMENT, NO HARM, NO MEDICAL INTERVENTION, PATIENT IS DOING WELL."

Additional Manufacturer Narrative

(B)(4). THE REPORTED ISSUE 'CATHETER FOLDED' COULD NOT BE CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE UNIT OF THE CATHETER. NO DAMAGE OR ABNORMALITIES WERE OBSERVED ON THE UNIT. THE NEEDLE WAS NOT RETURNED TO CONFIRM ANY DEFECTS PRESENT. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NO HARM. NO MEDICAL INTERVENTION WAS CARRIED OUT. PATIENT CONDITION WAS FINE. A DHR REVIEW WAS COMPLETED FOR AND NO ISSUES OR NON-CONFORMITIES WERE NOTED. IT IS UNKNOWN IF THE NEEDLE COULD HAVE CAUSED ANY FOLDING ISSUES DURING USE ALONG WITH CATHETER. BASED ON LIMITED INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "INTRODUCER CATHETER FOLDED BACK ONTO ITSELF PREVENTING ADVANCEMENT. UPON REMOVAL THE CATHETER WAS FOUND TO BE INTACT BUT FOLDED. THERE WAS PATIENT INVOLVEMENT, NO HARM, NO MEDICAL INTERVENTION, PATIENT IS DOING WELL."