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	03/26/2020
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 feeding set leaked while operating.The feed leaked all over the pump and floor.
Additional Manufacturer Narrative
Lot number provided by the customer was not a valid lot number.Lot number is unknown.Additional information a device history record (dhr) review could not be performed because the stated lot number is not a valid number.No sample was returned to the manufacturing site, but a picture was provided for evaluation.Examining the picture, a line can be seen detached from the cassette, causing leaking.No formal investigation action is being taken at this time because no trend has been detected.The root cause and corrective actions could not be identified without a physical sample to evaluate.This complaint will be closed with no further action.If a sample is received at a later date, the complaint will be reopened for investigation.This complaint 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: 9978107
• Report Number: 1282497-2020-09010
• Device Sequence Number: 11304775
• 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): 05/14/2020

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: 1919600020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1