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

Catalog Number GJS-1400-SHETTY

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: preamendment (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a patient pulled out her peg-j tube on (b)(6) 2018 and a new tube was placed the following day.To date, additional information regarding the event, patient status and adapter used is unknown.As reported, there were no other adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Additional information/clarification: after further review of the record, it was determined that it should be clarified that the patient pulled out the tube (b)(6) 2018, the tube was replaced (b)(6) 2018 and (b)(6) 2018, per the customer: "the clinician was asking for the appropriate adapter because they provided the wrong one, and the pump is intermittently alarming high pressure.He was advised to contact the physician who placed the tube for the appropriate adapter".At this time additional information is unavailable.Corrected data: occupation.This event is still under investigation.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation - evaluation.A review of the documentation, drawing, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed and we are unable to determine whether the catheter is non-conforming or not.Document review was conducted and has established that proper procedures are in place to identify/prevent this failure mode prior to distribution.The ifu was reviewed and identified three steps involved with securing the catheter.Due diligence was conducted and unsuccessful when trying to obtain information on whether these steps were followed properly.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Ifu states: "5.Pull suture end tight to form a loop configuration in the pylorus and inject contrast to verify catheter tip position within the jejunum." "6.Wrap suture around the catheter and secure with a knot, then trim off excess suture and slide the sleeve over the suture to prevent leakage." "7.Attach the catheter to the skin surface using the physician preferred method of attachment." based on the information provided, no product returned and the results of our investigation, the possible root cause was determined as product use or handling related (user technique).We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

• 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
• MDR Report Key: 7417654
• MDR Text Key: 105140567
• Report Number: 1820334-2018-00868
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: GJS-1400-SHETTY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUMP/ UNKNOWN ADAPTOR
• Patient Outcome(s): Required Intervention