MAUDE Adverse Event Report: COOK INC ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Catalog Number	ULT14.0-38-35-P-12S-WOGS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the cap of the feeding adapter did not close well and it was very "loose-fitting".There were no reports of adverse effects to the patient as a result of this product problem.

• Brand Name: ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7273038
• Report Number: 1820334-2018-00523
• Device Sequence Number: 16579880
• Product Code: KNT
• UDI-Device Identifier: 00827002098916
• UDI-Public: (01)00827002098916(17)190616(10)7049215
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ULT14.0-38-35-P-12S-WOGS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1