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	02/10/2020
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. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the kangaroo connect 500ml feeding bag was leaking inside the cassette at the connection where the hard plastic white piece meets the tubing inside of the cassette, right beside where the small black circular piece is within the cassette.The formula being used was neocate.There are no other details available.
Additional Manufacturer Narrative
H 3 evaluation summary the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.A sample was received at the manufacturing plant for evaluation.During visual inspection, leaking was detected between the connection of the tubing line and the cassette.The root cause could be determined to be related to the manufacturing process.Nor formal investigation action is being taken because the failure mode is not a trend.This complaint 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: 9734503
• Report Number: 1282497-2020-08936
• Device Sequence Number: 361667
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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
• Device Lot Number: 191440070
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1