MAUDE Adverse Event Report: COVIDIEN CONNECT FEED STE 1000ML NS; PUMP, INFUSION, ENTERAL

Model Number	77100FD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
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 during the feeding the patient was fairly active in bed and the feeding set's tube broke causing an unknown quantity of milk to spill on the floor and bed.There was no patient injury.
Additional Manufacturer Narrative
Updated the unique identifier (udi) number from the inaccurate udi number to the correct udi number.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) review could not be done because the lot number was not available.One used sample was received for evaluation.Visual and functional evaluation was performed, and it was found that the line was detached from the cassette.The root cause and action plan will be documented through formal corrective and preventative action (capa).This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: CONNECT FEED STE 1000ML NS
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9538824
• Report Number: 1282497-2020-08849
• Device Sequence Number: 14068665
• Product Code: LZH
• UDI-Device Identifier: 00763000175634
• UDI-Public: 00763000175634
• 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,Followup
• Report Date (Section B): 03/10/2020

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: 77100FD
• Device Catalogue Number: 77100FD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 12/17/2019
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/02/2020; 03/10/2020
• Patient Sequence Number: 1