MAUDE Adverse Event Report: REDO SINGLE LUMEN TPN CATHETER SET

Catalog Number C-TPNS-6.5-90-REDO

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This information is unavailable as this device is not actively sold in the u.S.; however, this device meets the criteria for same/similar to another device manufactured by cook that is sold in the u.S., thus prompting this report.First name: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a tear was noticed in a redo single lumen tpn catheter during flushing at home.It was also reported that resistance was noted during flushing.The tear was noted near the area where the "suture wing is fixated".Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

On (b)(6) 2020, the customer reported that a competitor repair kit was used on the patient, and that it was the competitor device that failed.On (b)(6) 2020, the completed device failure analysis (dfa) indicated that a damaged, non-cook device was returned.Therefore, since there is no alleged malfunction with a cook device involved in this incident, this complaint will be close / cancelled and no further reports regarding this event will be submitted by cook.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• MDR Report Key: 10484149
• MDR Text Key: 206769910
• Report Number: 1820334-2020-01612
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1