The customer reported the following general complaints.These issues occurred during administration of total parenteral nutrition (tpn): the redo single lumen tpn catheters sometimes become loose or spin where the hard plastic goes into the silicone.These events are captured in mfr.Report # 1820334-2019-01311 and mfr.Report # 1820334-2019-01313.While attempting to repair the redo single lumen tpn catheters, it is sometimes found that the repair kits are also loose or spin where the hard plastic goes into the silicone.This problem is discovered with the repair kits before patient contact.The procedures are completed with repair kits of the same type that do not have this problem.This report captures one event with a 3fr device.The other event with a 4fr device is referenced in mfr.Report # 1820334-2019-01312.As reported, these occurrences have not caused or contributed to any adverse effects to the patients.Additional event details have been requested.At the time of this report, this is the only information available.
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Investigation ¿ evaluation.A review of the complaint history, documentation, trends, instructions for use (ifu), quality control and specifications of the device was conducted during the investigation.The complaint device was not returned.Therefore, a physical investigation of the returned complaint device could not be completed.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record could not be completed, as the lot information is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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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