It was initially reported there have been several instances over the past year where tpn catheters, reported as either c-tpns-4.0-65-redo or c-tpns-6.5-90-redo have broken down prematurely.It was further reported that there have been cases where the outer lumen is coming away from the inner lumen and of ballooning out and exposing the inner sheath.The reported devices were used predominantly with pediatric patients for total parental nutrition.Five devices were saved to be returned to cook.At this time it was clarified that the outer lumen is separating from inner lumen/fracture breaking approximately 4 inches from hub.When the separation was noted, the patient received another tpn line.The first returned device is the subject of this report.The related mdr reports are: 1820334-2019-00423, 1820334-2019-00424, 1820334-2019-00425, and 1820334-2019-00426.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: d10 - product received on 06mar2019 investigation - evaluation a review of the instructions for use, quality control, as well as a visual inspection of the returned device was conducted during the investigation.One 4.0fr device was returned for evaluation.A visual exam noted that the silicone has pulled away from the hub, causing a separation of material.The cause is unknown.Additionally, a document-based investigation evaluation was performed.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record could not be completed, as the lot number is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: silicon catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce risk of catheter rupture.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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