TWIN LUMEN URODYNAMIC CATHETER

Additional Manufacturer Narrative

H6. 68 DEVICE FROM SAME LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES. 18 EACH OF THE PRODUCT FROM THE SAME LOT NUMBER WERE RETURNED ON 11/17/97. THE REASON FOR THE RETURN OF THESE DEVICES WAS THAT A LEAK WAS FOUND AT THE Y-JUNCTION OF ONE OF THE CATHETERS. SIX DEVICES WERE TESTED IN ALL. INITIAL TESTING OF SEVERAL DEVICES INCLUDED VISUAL EXAMINATION OF EYES, PORT, Y-JUNCTION, ETC. ONE OF THESE CATHETERS WAS CUT FOR CLOSER EXAMINATION, REVEALING NO ABNORMALITIES. FURTHER PERFORMANCE TESTING WAS DONE WITH THE DEVICES. THIS INCLUDED THE MANNER IN WHICH THE DEVICE WOULD BE USED BY A HLTH PROFESSIONAL. WHEN THIS DID NOT SHOW ANY LEAKS, FURTHER TESTS WERE PERFORMED. THE CATHETERS WERE PURGED AT BOTH ENDS, THE CATHETERS WERE FILLED AS SPECIFIED AND THE DISTAL END OF THE CATHETER WAS TIED IN A TIGHT KNOT FOLLOWED BY CAPPING THE PORT. THIS PROCEDURE WAS DONE TO TWO CATHETERS. AGAIN, THE CATHETERS DID NOT LEAK. WITHOUT THE CATHETERS INVOLVED IN THE INCIDENT, IT CANNOT BE DETERMINED AS TO THE EXACT CAUSE OF THE COMPLAINT.

Description of Event or Problem

IT WAS STATED THAT DURING REGULAR URODYNAMIC CHECK ON TWO SEPARATE OBESE FEMALES, CATHETER WAS IN PLACE AND PT WAS ASKED TO COUGH, TO CHECK PRESSURE DEFLECTION, IT WAS FOUND THAT THERE WAS NO DEFLECTION. IT WAS STATED THAT PT WAS THEN LAID IN FLAT POSITION AND FOUND THAT THE DISTAL END OF THE CATHETER WAS BLOCKED AND A LEAK WAS NOTED AT JOINT OF Y-JUNCTION BY NURSE. NURSE WAS PERFORMING THE PROCEDURE. A ONE SIZE LARGER CATHTER WAS USED IN REPLACEMENT FOR THIS CATHETER AND WORKED FINE. NO HARM TO PT.