The extension tube (vein side) was cracked. The incident occurred after 3 days after placement. No patient injury.

Findings: the complaint that the venous lumen burst is confirmed as user related. The implicated product and the product received for evaluation is a 24cm dual lumen catheter. Both of the catheter's extension legs are discolored an iodine-like yellow. The discoloration is relatively dark throughout the extension tubing and becoming lighter just distal to the rotatable suture wing. The printed volume indicators on each extension leg (adjacent to the bifurcation) are partially worn away. A burst like aneurysm is observed on the venous lumen. Microscopic (5x- 20x) examination of the burst site is jagged and irregular and shows the discoloration has permeated through the tubing surface. The od of venous extension leg around the burst site is distended with an aneurysm-like bulge. The tubing around the burst site is elastically weakened and plastically deformed. The burst site is 0. 2" distal to the venous connector, the edges of the burst site area are torn and irregular. It appears that an aneurysm occurred in the polyurethane before the tubing actually ruptured causing a distended region around the burst site. There is no evidence of mechanical or sharp insturment damage to either extension leg. The iodine-like stain, distended tubing are characteristics associated wtih exposure of polyurethane material to antiseptic ointments containing polyethylene glycol (peg). Tactual examination of the extension leg shows both to be excessively pliant in the opaque areas. Catheter patency is demonstrated by infusing water through each individual lumen with a 12cc syring. During infusion a leak was observed on the venous lumen. The complaint that the venous lumen burst is confirmed as user related. The user indicated that the extension tubing was cracked. The elastic deformation around the ruptured area is typical when polyurethane is damaged due to over pressurization. The tubing may have also been weakened by the use of alcohol or acetone on the catheter and ruptured when the user infused with excess force against resistance. The instructions for use accompanying this product inform the user that the use of alcohol or acetone based antiseptics to clean the catheter or skin site may adversly affect the clamping extensions and luer lock connectors. Infusion should not be forced when resistance is encountered.