MAUDE Adverse Event Report: COVIDIEN J001FO 1000ML JOEY FEED BAG TYPE X30; PUMP, INFUSION, ENTERAL

Model Number J001FO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

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 Description

The customer reported that the fluid leaked from around the magnet.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.However, all records from manufactured lots are reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The actual complaint sample (1 each) was returned for review without packaging or lot number identification.The sample was evaluated by testing the pump.The results of the test found that the nutrient fluid flowed slowly and the flow that came from the silicone tube leaked from the pin hole.Therefore, the actual complaint sample was confirmed.A formal corrective/preventative action (capa) was opened with the supplier to address the root cause and corrective actions.Included in the capa are process improvements for the inspections of the process router parts and tooling modification and validation.Currently the capa is pending implementation and validation said to be completed within the current year.

• Brand Name: J001FO 1000ML JOEY FEED BAG TYPE X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 9370689
• MDR Text Key: 167860942
• Report Number: 8040459-2019-00506
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J001FO
• Device Catalogue Number: J001FO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Patient Sequence Number: 1