(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.As a lot number for the device was not received a review of the device history record (dhr) could not be conducted.Results: at this time halyard is pending the receipt of the device and as the investigation is still in progress, results are not available.One the device is received, testing will be performed and results will be provided upon completion.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.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.Device return anticipated.
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Method: the device was reported as not available for return and analysis.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.The instructions for use (ifu) specifies the following: warnings "do not suture through catheter to avoid catheter breakage during removal.Catheter removal remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter.Remove dressing and loosen the adhesive strips at catheter site (figure 10 on page 2).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.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.After removal, check distal end of catheter for black marking to ensure entire catheter was removed." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.It was reported that the nurse experienced difficulty upon pulling the catheter and it appeared stretched and pulled apart; therefore, the use error may have contributed to the reported event.However, without the device, the complaint in not able to be evaluated and a root cause cannot be determined.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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