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	01/25/2020
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 formula had been poured into the bag and was intact.The bag was then placed in the fridge for several hours and noted to be leaking formula from the bottom of the pouch.The tubing was not involved.The staff estimated that this was the first day of bag use but was unsure if previous feed had been delivered.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.One used sample was received for evaluation and one photograph.During the visual evaluation no issue was detected however during the functional evaluation, a sealing issue was detected causing leaking.The reported condition was confirmed.A root cause could be identified as related to a manufacturing/production process and a corrective action will be limited to trending for this issue for any future occurrences as a part of the complaint review process.

• 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: 9739953
• Report Number: 1282497-2020-08938
• Device Sequence Number: 1802334
• 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): 04/22/2020

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: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1