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-6.5-90-REDO

Device Problem Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 07/24/2014

Event Type  Injury  

Event Description

A (b)(6) male pt underwent a broviac removal and reinsertion.The device was inserted into the child at the hospital.After the procedure, while the child was at home, there was swelling under skin noted by his parents.The child was brought to the er by his parents.An x-ray was done.While flushing, additional swelling was noted.The x-ray revealed leakage.Two days later, the child had the device replaced.After removal, it was noticed that the removed device had 2 pinholes.The pt required the additional procedures of an x-ray, a catheter removal and a catheter reinsertion due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects other than having to endure the additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

During our investigation, a functional test, and a review of the complaint history, instructions for use (ifu), quality control (qc), and a visual inspection of the returned product was conducted.The visual inspection noted that 13.5 cm of the catheter was returned.Functional testing revealed that when injected, no leakage was detected.Per quality control specification, there is confirmation that the overall catheter surface is clean without excessive imperfections or damage.This product is shipped with an instructions for use, which states warnings, precautions and instructions for use.Based on the information provided and the results of our investigation, we are unable to determine with certainty why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, the addition of this complaint does not change the conclusion that no further risk reduction is required.

• 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: rita harden, dir ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4128851
• MDR Text Key: 4935029
• Report Number: 1820334-2014-00442
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2014

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-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 4 YR