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

Model Number 8884711253

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record file was reviewed indicating that the product was released meeting all quality standard requirements.The physical sample has not been received for evaluation however the customer did provide a digital photograph.According to the photograph, t tube kinked was observed.Since an evaluation of a physical sample could not be completed, the root cause was not identified.However, based on previous evaluations from physical samples received with similar failure mode the most likely root cause is due to inadequate use of the product because the instructions of use were not followed accurately.According to the literature included in the product, the failure mode could occur during the medical procedure of insertion.It states, ¿to estimate insertion depth, use the tube to measure the distance from the tip of the patient¿s nose to the earlobe and from the earlobe to the xiphod process for gastric placement¿.This measurement determines the tube length therefore if the tube was inserted more than specified in the procedure, a possible coiling or kink around the stomach could occur.Due to the extreme caution, this device should only be inserted by a trained clinician.At this time, no corrections are required as the process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that there is knocking on the probe body.A photo provided from the customer show that the enteral feeding tube has a kink.No patient injury was reported.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7337915
• MDR Text Key: 102353727
• Report Number: 9612030-2018-00030
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 703890864X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1