MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	C-TPNS-7.0D-65-REDO
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Lymphoma (3263)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 redo double lumen tpn catheter set fractured approximately 2-3 cm below the hub.Following the chamber-pot in tubing, the flow halted.The line was clamped quickly to ensure the influx of therapy would discontinue.The device was removed.The device had been in place for 36 days in the right subclavical vein and delivered 5 therapies with an infusion speed of 60 ml/hr.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: additional information received (27jul2018) identified that per the customer no damage or stress to the device was noted after implantation.At this time, it was also reported the device was replaced with another after removal.Further information received (08aug2018) identified the access site for the device was the venous subclavia dextra (right subclavian vein) and the treatments through the device were: cytostatics, albuminous, antibiotics, antiemetics, corticosteroids, analgetics, and infusions.It was also clarified that during the use of the device from 27apr2018 through 04jun2018 there were 3 blocs of therapies and the device was used all the time for almost 5 weeks, only when patient was at home-1 week it wasn't used.D10-device available for eval:yes; product received on: 28jun2018.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, trends, and a visual inspection/functional test of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed a leak was found beneath the manifold.A closer observation noted a 1 mm split in the catheter material.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Ifu states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering 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.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7644935
• Report Number: 1820334-2018-01825
• Device Sequence Number: 134631
• Product Code: FOZ
• UDI-Device Identifier: 00827002079021
• UDI-Public: (01)00827002079021(17)201019(10)8279077
• Combination Product (Y/N): N
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018
• Report Date (Section F): 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2020
• Device Catalogue Number: C-TPNS-7.0D-65-REDO
• Device Lot Number: 8279077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 12