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

Model Number 775759

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 04/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the unit presented a blockage during use that would not allow nutrient flow.The issue was noticed during infusion.

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.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: 6554255
• MDR Text Key: 74753257
• Report Number: 2936999-2017-05197
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2019
• Device Model Number: 775759
• Device Catalogue Number: 775759
• Device Lot Number: 160570200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2016
• 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