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)
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 large air gaps in the tubing.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported large air gaps in the tubing.No patient injury/harm was reported.This report refers to product code 763656, joey 1000ml pump set, with lot number 202020031, which was manufactured on 28-jul-2020.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.Lot and failure mode trending was reviewed an no trends were identified.One (1) used sample was returned for evaluation.Visual and functional testing performed confirmed the report of air in line.An investigation has been initiated to determine the the root cause and develop an action plan, if required.This complaint will be used for tracking and trending purposes.

• 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: 11753049
• Report Number: 1282497-2021-10138
• Device Sequence Number: 14495155
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1