MAUDE Adverse Event Report: COVIDIEN KANGAROO CONNECT FEEDING SET 500 ML; PUMP, INFUSION, ENTERAL

Model Number 77500FD

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported leaking from the tubing for the enteral feeding set before in-use on patient.

Manufacturer Narrative

The customer was unable to provide a lot number therefore a device history record could not be reviewed.A sample was not returned to manufacturing, but a photograph was provided for analysis.An examination of the photograph depicts that the line was detached from the cassette causing the unit to leak.A probable root cause could be manufacturing related or could be related to the manner that the product is handled if the silicone tubing is pulled, causing the detachment.Without the actual sample to evaluate, this complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: KANGAROO CONNECT FEEDING SET 500 ML
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9439586
• MDR Text Key: 170041300
• Report Number: 1282497-2019-08811
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• 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
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 77500FD
• Device Catalogue Number: 77500FD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Patient Sequence Number: 1