E3- occupation: purchasing buyer.G4- pma/510(k) #: preamendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
|
It was reported that the catheters from triple lumen polyurethane central venous catheter sets were experiencing "clogging issues".Related complaints, with different rpn #s, filed under patient identifiers: (b)(6).Additional information regarding the event and patient outcome has been requested but is currently unavailable.
|
Investigation ¿ evaluation.It was reported that the catheter lumens from triple lumen polyurethane central venous catheter sets would occlude while in use.Related complaints, with different rpn #s, are filed under patient identifiers: (b)(6).Despite multiple attempts to attain additional details, it is unknown if any patients were impacted by this occurrence.Reviews of the complaint history, instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint devices.Cook reviewed the sales history for this customer over a three year period and was unable to identify the complaint lot.The device history record (dhr) could not be reviewed.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ulmbhce_rev9 [uncoated and heparin-coated central venous catheters] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: precautions: for heparin coated devices, standard flushing procedures are recommended.Suggested catheter maintenance: before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.Instructions for use: prepare the catheter for insertion by flushing each of the lumens and clamping or attaching the injection caps to the appropriate extensions.Leave the distal extension uncapped for wire guide passage.The information provided upon review of the dmr and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no device return, and the results of the investigation, cook has concluded user error contributed to this event.Communication between the user facility, customer representative, and clinical team revealed the user may not have been properly flushing or priming the lines prior to insertion.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.
|