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

Model Number 763656

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

According to the reporter, during use the formula gets clogged in the tubing and will not push through.No patient harm.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6949587
• MDR Text Key: 89737260
• Report Number: 1282497-2017-05408
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 763656
• Device Catalogue Number: 763656
• Device Lot Number: 176950167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• 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