Investigation ¿ evaluation.Issues beginning in november 2020 were reported with unknown picc devices from unknown lots.As reported, eleven piccs have been removed and replaced as a result of clotting/thrombus formation preventing blood return.The patient outcomes are unknown.Cook became aware of these events upon being notified by (b)(6) hospital.Reviews of the complaint history, quality control procedures, and instructions for use (ifu) 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product¿s design history file (dhf) has controls in place to address the failure.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Review of the sales records to the user facility over three years prior to the date cook was made aware could not sufficiently narrow down the lot number.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: warnings: catheter tip position should be verified by x-ray and monitored on a routine basis.Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall.Tip position should appear to be parallel to vessel wall.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance: catheter entry site must be prepared and maintained in a manner consistent with standard procedure for central venous catheterization.After catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Note: if microclave or other needleless adapters approved for saline only lock are used, saline only catheter lock may be used.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin lock should be reestablished after every use, every 24 hours, or in accordance with the approved facility protocol if catheter is unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.The information provided upon review of the dmr, ifu, and dhf suggests that the devices were manufactured to specification, and that there are no nonconforming devices in house or out in the field.Based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.It is possible that manipulation of the devices after placement contributed to the failure mode.However, minimal information was provided regarding the procedures, patients, and maintenance of the devices so this cannot be confirmed.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.
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