MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML FEED/FLUSH SET; PUMP, INFUSION, ENTERAL

Model Number	763662
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 stated the tubing was melted to itself and when she tried to separate it, the tubing leaked.There was no harm to the patient.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.One used sample presumed to be involved in the reported incident was returned for evaluation.Based on the visual and functional inspection was performed and the reported issue was not evident.The complaint report will be treated as not confirmed based on the results of the evaluation therefore a root cause could not be identified as related to a manufacturing/production process.Corrective and preventative actions will be limited to tracking and trending at this time.

• Brand Name: JOEY 1000ML FEED/FLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9728069
• Report Number: 1282497-2020-08935
• Device Sequence Number: 2482701
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• 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): 05/19/2020

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: 763662
• Device Catalogue Number: 763662
• Device Lot Number: 183550166
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/19/2020
• Patient Sequence Number: 1