MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461438

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that a 6.5 fr polyurethane feeding tube was secured in place.The purple cap/top accessed to hook up the syringe to check placement and purple top disconnected.There was no patient injury reported.

Manufacturer Narrative

Two decontaminated samples were received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the defect was confirmed; the separation of the purple connector can be observed.A root cause could not be determined.As part of continuous improvements, a corrective action has been opened to implement effective solutions to prevent the reoccurrence of the reported condition.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; cuidad industrials; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7566623
• MDR Text Key: 110033832
• Report Number: 9612030-2018-00100
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521067950
• UDI-Public: 10884521067950
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 461438
• Device Catalogue Number: 461438
• Device Lot Number: 1801619964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1