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

Model Number	77100FD
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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 the feeding bag broke at the joint where the tube goes into the cartridge and leaking occurred.There was no harm to the patient.
Additional Manufacturer Narrative
Lot number was added to section d4.The device history record (dhr) review shows evidence that the product was released according to all established procedures and qa documentation.One sample was received for evaluation.Visual and functional test was performed and the reported issue was confirmed.As part of continuous improvements, a corrective action has been opened to determine the root case and action plans.These actions will be designed to prevent the reoccurrence of the reported defective condition.

• 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: 9557691
• Report Number: 1282497-2020-08859
• Device Sequence Number: 19394664
• 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): 03/20/2020

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: 191930021
• 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: 01/07/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1