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-5.0-65-REDO

Device Problem Difficult to Advance (2920)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 09/24/2014

Event Type  Injury  

Event Description

The physician found it was impossible to advance the 0.18" wire guide through the catheter to make an exchange; therefore, he had to cut the catheter out one inch at a time, as otherwise, it would kink and twist on the external portion.A section of the device did not remain inside the pt's body.The pt did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Manufacturer Narrative

A review of complaint history, review of instructions for use (ifu) pamphlet, and review of quality control (qc) procedures were conducted during the investigation.No product has been returned.Quality control inspection for the device confirms the catheter lumen is open and free of obstruction.And the catheter surface is void of imperfections or damage.This product is shipped with and instructions for use, which provides warnings, precautions and instructions for use.The root cause of this event was undetermined, based upon the information provided.The appropriate internal personnel have been notified and we wil`l continue to monitor for similar complaints.

• 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.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4208644
• MDR Text Key: 4967738
• Report Number: 1820334-2014-00533
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TPNS-5.0-65-REDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• 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
• Patient Outcome(s): Required Intervention