A pt had a #10 j-p drain placed intraoperatively, which was removed on postoperative day #1. Upon attempted removal, the drain snapped and only the distal portion came out. The pt was returned to the o. R. For definite removal. It was found that no stitch was entrapping the drain.

The product sample was received decontaminated into the specimen container, inside a biohazard-labeled zip-lock bag in 2003. Visual examination showed that it is 4. 25 inches in length, a portion of catalog su130-1311, jp 10mm flat silicone drain, full length perforated. The molded lps flat drain section shows that it was divided with a slant cut at approx 3. 50 inches from the drain/tubing junction area. The remainder of the flat drain section was not received. It also showed traces of dried body fluid inside the drain. Visual inspection revealed that the clear silicone tubing broke at approx 0. 75 inches from drain/tubing junction area. The remainder of the clear silicone tube section was not received. Microscopic examination revealed a wavy/jagged edge at the fracture site and no distortion in the adjacent drain, which indicates that the drain was not stretched (elongated) to failure. The characteristics of the fractured area and the absence of any tubing distortion are similar to those failures that are caused by puncture by a sharp instrument. Without the product lot number co cannot trace the dhr, quality testing performed and corresponding results. If this should recur, it would be helpful if the lot number to the drain were available for review. However, historical eval of broken drains usually determines that alleged complaints may be caused by accidental nicking or puncturing of the drain during placement or removal which initiates tear propagation upon pull force loading during wound drain removal. While this analysis cannot conclusively determine the cause for failure, the observations do not lead co to believe that there was an inherent weakness in the material itself. Moreover, it cannot be concluded with any certainty when or where the drain surface was compromised in such a fashion to lead to breakage. Product info data sheet (pids) provides detailed info regarding precautions for using these drains. Warnings/complications; specifically, co warns against any form of handling that may result in breakage of the drains and tubing portions; for example nicks, cuts and tears caused by punctures, sutures or sharp instruments. This includes handling gently and without excessive force. Lastly, leaving the drain implanted for any period of time, which allows for tissue ingrowths around the drain and into the holes, may cause breakage on removal.