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

Catalog Number	GJS-1400-SHETTY
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2015
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 device had been in situ for 4 months in a patient with a pre-existing condition of gastroparesis.The tube was reported to have split from end cap to site of skin.With pre-existing condition, the tube was reported to have split from end cap to site of skin.Additional information provided that another device (not cook) was placed.The tube had a split from the proximal end to entry at skin.It was suspected that patient has pulled string hard deliberately, due to psychological issues.The split started from 1 cm from the red cap to the skin.It looks like the string has been pulled through the split.The patient was not feeding at the time and away from the ward.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 7272996
• Report Number: 1820334-2018-00513
• Device Sequence Number: 13714180
• Product Code: KNT
• UDI-Device Identifier: 00827002072763
• UDI-Public: (01)00827002072763(17)150201(10)3122347
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: GJS-1400-SHETTY
• 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