MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 775659

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the spike set showed a leak at the insert below the connector.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.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: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 37 insurgentes blvd; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; 37 insurgentes blvd; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7711670
• MDR Text Key: 114886729
• Report Number: 1282497-2018-00602
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• 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,Followup,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 160850122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 10/02/2018; 10/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2016
• 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