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

Model Number 8884721055

Device Problem Kinked (1339)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that two attempts were made to place the nj radioscopically but was not feasible due to lack of patient cooperation and his difficulty in swallowing.The two tubes presented with a kink in the 40cm.On medical advice, the pump was started and the catheter filled with 5ml.The patient was given medical treatment for a fever and an x-ray was taken to assess the tube location.

Manufacturer Narrative

The below investigation was updated to reflect the two samples that were returned for analysis.A device history record review could not be performed because a lot number was not received with the complaint.Two samples without original package or lot number were received for evaluation.After performing visual inspection the reported condition was confirmed.The tubes had a kink present.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.One sample without original package or lot number was received for evaluation.After performing visual inspection the reported condition was confirmed.The tube had a kink present.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.One sample without original package or lot number was received for evaluation.After performing visual inspection the reported condition was confirmed.The tube had a kink present.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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: 7593112
• MDR Text Key: 110850539
• Report Number: 9612030-2018-00104
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884721055
• Device Catalogue Number: 8884721055
• Device Lot Number: 414780964X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1