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

Model Number	77500FD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the feeding set was leaking from the cassette as well as from the top of the bag.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record review of the reported lot number was not reviewed as the lot number was not provided.One sample was received for evaluation.A visual and functional evaluation was performed and did not demonstrate leaking.The reported condition could not be confirmed.The root cause and corrective action plan could not be identified as the sample did not leak and did not relate to a manufacturing/production process.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
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9586131
• Report Number: 1282497-2020-08865
• Device Sequence Number: 3389662
• Product Code: LZH
• UDI-Device Identifier: 10884521190849
• UDI-Public: 10884521190849
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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
• Operator of Device: No Information
• Device Model Number: 77500FD
• Device Catalogue Number: 77500FD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/30/2020
• Patient Sequence Number: 1