(b)(4).Method: the device was not reported as available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.It was reported that a lot of pressure was exerted on the catheter while pulling it out.The instructions for use (ifu) specifies the following: "grasp catheter close to skin and gently pull to remove.The catheter should be easy to remove and not painful.Do not tug or quickly pull on catheter during removal (figure 11 on page 2).Cautions: if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.It¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.For additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q* system.Do not cut or forcefully remove catheter." information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.
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