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

Model Number J001FO

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2019

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 there was leaking at the valve of the device during use.

Manufacturer Narrative

H 3: evaluation summary: the device history record (dhr) for the lot was not reviewed because the lot number could not be provided.However, all records from the manufactured lots are reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The complaint sample was returned for review without the package.The sample was evaluated by the pumping test.The result found leaking at the valve.This confirmed the reported condition.The valve is a supplied component.The supplier determine that the root cause came from the machine possibly not having received the right maintenance.The sensor did not have documented periodic inspections.Training will be refreshed, and a visual control will be established for the operator to conduct 100% screening before assembly.A full review of the current status of the pistons and sensors was performed for the maintenance of the machines.Monthly and weekly reviews of the pistons were added to the machine job plan.This complaint will be used for tracking and trending purposes.

• 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: 9349997
• MDR Text Key: 167245533
• Report Number: 8040459-2019-00503
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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 Operator: No Information
• Device Model Number: J001FO
• Device Catalogue Number: J001FO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 01/20/2020
• Patient Sequence Number: 1