MAUDE Adverse Event Report: COOK INC ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event unknown.(b)(4).Event is still under investigation at this time.
Event or Problem Description
04feb2016- the female patient reported a stoma site infection.The patient reported that she had been on two week regimen of augmentin twice daily for her stoma infection.She was not able to recall when the stoma infection started.She reported that it was found by her visiting nurse who noted yellow discharge from the stoma site with no color, no redness, no pain, no swelling and no fever.The patient reported that the discharge was getting better.05feb2016- update received from the physician stated that this was placed on (b)(6) 2015.
Additional Manufacturer Narrative
(b)(4).Investigation / evaluation: during the course of the investigation a review of the complaint history, quality control, manufacturing instructions, device history record, drawing, specifications, and instructions for use (ifu), was conducted.There is no evidence to suggest that the product was not manufactured to specification.The product is packaged with ifu.The ifu includes device description and intended use, instructions for placement, warnings and precautions and post placement care instructions.The ifu states that the device is "supplied sterilized by ethylene oxide has in peel-open pouches.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." as no product was returned and based on the limited information provided, we are unable to determine with certainty the root cause of this complaint.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.Per the conclusion of the quality engineering risk assessment, additional risk reduction is not required.
Event or Problem Description
On 04feb2016- the female patient reported a stoma site infection.The patient reported that she had been on two week regimen of augmentin twice daily for her stoma infection.She was not able to recall when the stoma infection started.She reported that it was found by her visiting nurse who noted yellow discharge from the stoma site with no color, no redness, no pain, no swelling and no fever.The patient reported that the discharge was getting better.On 05feb2016- update received from the physician stated that the device was placed on (b)(6) 2015.

• Brand Name: ULTRATHANE SHETTY SINGLE LUMEN GASTROJEJUNOSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5470851
• Report Number: 1820334-2016-00121
• Device Sequence Number: 357012
• Product Code: KNT
• UDI-Device Identifier: 00827002072763
• UDI-Public: (01)00827002072763(17)180820(10)6043479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2016

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GJS-1400-SHETTY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 06/07/2016
• 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: Other