MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Catalog Number	C-UTLM-701J
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k081113.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a triple lumen polyurethane central venous catheter set was used during a research study to retrieve cerebral venous blood samples.The line was in place for approximately 5 hours and samples were taken every 5-10 minutes.The line was flushed frequently with saline after samples were taken.Significant clots within the internal jugular vein were observed and measured via duplex ultrasound.The progression of these clots were tracked and said to dissipate.As reported, the issue of clotting was not noted when different catheters were used.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Correction: the lot number for this device is unknown.Additional information: initially, the customer reported clots formed on the catheter.Additional information provided on 15-aug-2018 from the customer stated the clots were seen via ultrasound along the outside of the device.The device was removed, the patient was given aspirin and a week later the clots were absent during a follow-up echocardiograph.The device did not malfunction nor have potential to cause of contribute to patient harm.This incident does not meet the criteria for a reportable event.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or product malfunction as the device did not malfunction nor have potential to cause or contribute to patient harm.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.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7660213
• Report Number: 1820334-2018-01998
• Device Sequence Number: 10801222
• Product Code: DQY
• UDI-Device Identifier: 00827002029378
• UDI-Public: (01)00827002029378(17)190323(10)6835627
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 03/23/2019
• Device Catalogue Number: C-UTLM-701J
• Device Lot Number: 6835627
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 88