MAUDE Adverse Event Report: COOK INC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lumens of a cook turbo-flo over-the-wire double lumen peripherally inserted central venous catheter occluded.The user was able to flush the lumens but was unable to withdraw blood.A thrombolytic medication (2mg) was required to restore patency in the lumens.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The report indicated "noted to be an increased incidence of occluded piccs in the week" requiring the thrombolytic medication.Further information has been requested regarding the increased incidence but has not been provided at the time of this report.
Additional Manufacturer Narrative
D1 (device name): turbo-flo over-the-wire double lumen peripherally inserted central venous catheter set e1 - customer (person): postal code: (b)(6) - occupation: senior clinical risk advisor.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 - annex c code is c0708 - blockage identified.Investigation ¿ evaluation it was reported that a turbo-flo over-the-wire double lumen peripherally inserted central venous catheter set would flush but not withdraw blood.The line needed alteplase 2mg in the lumens to restore patency.The patient did not experience any adverse effects due to this occurrence.It was noted that there was an increase of occluded piccs in that week.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are sufficient inspection activities in place to identify this failure mode prior to distribution.A review of the device history record (dhr) of the final and subassembly lots found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was able to review product labeling.The product ifu, [t_upicotw_rev4] ¿turbo-flo over-the-wire peripherally inserted central venous catheters,¿ provides the following information to the user related 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.¿ product recommendations catheter maintenance ¿catheter entry site must be prepared and maintained in a manner consistent with standard procedure for ventral 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 sued immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.-catheter lock should b reestablished after every use or at least every 24 hours if 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 catheter lock.¿ evidence provided upon review of dmr, product labeling, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.It is unknown what maintenance was for the catheter, nor what was used to originally flush the device.There are instructions in the ifu to prevent lumen occlusion.The appropriate personnel have been notified.Per the 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.Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of 25nov2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on 04dec2023.Per fda-2008-n-0393, questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: "¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational." an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17480194
• Report Number: 1820334-2023-01044
• Device Sequence Number: 2711154
• Product Code: LJS
• UDI-Device Identifier: 00827002311428
• UDI-Public: (01)00827002311428(17)230702(10)13283206
• Combination Product (Y/N): N
• PMA/510(K) Number: K161496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-501-MPIS-OTW
• Device Lot Number: 13283206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown