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

Model Number	763656
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
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 there were air gaps 3-4 inches long appearing in the tubing between the pump and the patient.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation summary: the customer reported air gaps, 3-4 inches long, were seen in the tubing of the feeding set.Not patient injury/harm was reported.A device history record (dhr) 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 trend analysis did not identify a trend within the reported lot, nor for the reported failure mode.One sample was received for evaluation.Visual inspection and function testing performed confirmed the report of air in tubing line.The root cause of this confirmed failure is related to the manufacturing/production process.An investigation has been initiated to determine the root cause and establish and execute an action plan, if necessary.This product failure will continue to be monitored and trended.

• Brand Name: JOEY 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11100467
• Report Number: 1282497-2020-09821
• Device Sequence Number: 14399277
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 763656
• Device Catalogue Number: 763656
• Device Lot Number: 201500027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1