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	11/05/2019
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.  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 the feeding sets were leaking during feeding which caused an unknown volume of feed (breast milk) to be lost.
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.Two used samples were received for evaluation.Visual and functional evaluation was performed, and both have detached lines 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 street; mansfield MA 02048
• MDR Report Key: 9555203
• Report Number: 1282497-2020-08858
• Device Sequence Number: 438611
• Product Code: LZH
• UDI-Device Identifier: 10884521190825
• UDI-Public: 10884521190825
• 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): 03/10/2020

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
• Device Lot Number: 191300031
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1