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

Model Number	763656
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2021
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 joey feed pump was ringing off occlusion.The tube was checked for potency and then the feedline line was re-started.Once re-started, the feed line snapped and sprayed formula into nurse¿s face.The pump and the bag were changed with no other issues.There was no harm reported.
Additional Manufacturer Narrative
See section h6 evaluation codes (type of investigation): updated to 4118 - not yet determined as the investigation is currently underway.Section d1 / d2 (brand name): originally reported as 500ml pump set and should be 1000ml pump set.Section d4 (model number and catalog number): originally reported as 762055 and should be 763656, (unique identifier (udi) #): originally reported as (b)(4) and should be (b)(4).
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used sample was received for the evaluation.Upon visual inspection, re-attached silicone was observed.Functional inspection could not be performed due to the valve being stuck with food.Therefore, the returned sample is inadequate to be evaluated for occlusion.Based on the investigation, no root cause could be found related to manufacturing/production process.However, the probable root cause of detachment could be related to incorrect use of the product.At this time, a corrective and preventive action is not deemed necessary.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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11995547
• Report Number: 1282497-2021-10277
• Device Sequence Number: 10978033
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2022

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
• Device Model Number: 763656
• Device Catalogue Number: 763656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 06/10/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/21/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown