MAUDE Adverse Event Report: COVIDIEIN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	762055
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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 10 of the pump sets have been drawing air into tubing in 6 to 12 inch lengths of air.Formula was following the bag without issue, but air was seen as the tubing left the pump.There was no patient harm.
Additional Manufacturer Narrative
Investigation summary: the customer reported ten (10) of the pump sets have been drawing air into tubing in 6 to 12 inch lengths.No patient harm/injury reported.The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product lot and failure mode trending was reviewed and a trend was not identified.A total of four (4) samples were received for evaluation.Visual inspection and functional testing performed confirmed the report of air in tubing line.An investigation has been initiated to determine the root cause of this manufacturing/production process issue.This device failure will continue to be monitored and trended.

• Brand Name: JOEY 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEIN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10839198
• Report Number: 1282497-2020-09627
• Device Sequence Number: 17188002
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• 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): 03/08/2021

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: 762055
• Device Catalogue Number: 762055
• Device Lot Number: 201670024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1