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

Catalog Number GJS-1400-SHETTY

Device Problems Detachment Of Device Component (1104); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2015

Event Type  malfunction  

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 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
• Type of Device: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7272996
• MDR Text Key: 100471720
• Report Number: 1820334-2018-00513
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002072763
• UDI-Public: (01)00827002072763(17)150201(10)3122347
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GJS-1400-SHETTY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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