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

Catalog Number C-TPNS-4.0-65-REDO

Device Problem Break (1069)

Patient Problem Feeding Problem (1850)

Event Type  Injury  

Manufacturer Narrative

The exact rpn is unknown.It has been reported that the device may be c-tpns-4.0-65-redo or c-tpns-6.5-90-redo.(b)(6).Occupation: unknown.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 initially reported there have been several instances over the past year where tpn catheters, reported as either c-tpns-4.0-65-redo or c-tpns-6.5-90-redo have broken down prematurely.It was further reported that there have been cases where the outer lumen is coming away from the inner lumen and of ballooning out and exposing the inner sheath.The reported devices were used predominantly with pediatric patients for total parental nutrition.Five devices were saved to be returned to cook.At this time it was clarified that the outer lumen is separating from inner lumen/fracture breaking approximately 4 inches from hub.When the separation was noted, the patient received another tpn line.The fifth returned device is the subject of this report.The related mdr reports are: 1820334-2019-00422, 1820334-2019-00423, 1820334-2019-00424, and 1820334-2019-00425.

Manufacturer Narrative

Additional device information received on 19feb2019.Updated fields are brand name.

Event Description

There is no new event information to report.

Manufacturer Narrative

Additional information: product received on 06mar2019.Investigation - evaluation: a review of the instructions for use, quality control, as well as a visual inspection of the returned devices was conducted during the investigation.A total of three devices were returned for investigation.A visual exam notes that the hub on each of the catheters indicates that the catheter is a 4.0fr.Two catheters were returned with a clamp and one was returned without a clamp.The silicone of the 4.0fr device referenced in this complaint was found to be pulled away from the hub, causing a separation of material.The cause of this separation is unknown.Additionally, a document-based investigation evaluation was performed.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 could not be completed, as the lot number is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions.Silicon catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce risk of catheter rupture.Based on the information provided, examination of the returned products and the results of our investigation, a definitive root cause could not be established.Per the quality engineering 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.

Event Description

No new event description information to report at this time.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8332993
• MDR Text Key: 135943639
• Report Number: 1820334-2019-00426
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-TPNS-4.0-65-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention