MAUDE Adverse Event Report: COVIDIEN J011RO JOEY ADAPUTER TYPE X30; PUMP, INFUSION, ENTERAL

Model Number J011RO

Device Problem Air/Gas in Device (4062)

Patient Problems Discomfort (2330); Abdominal Distention (2601)

Event Date 07/14/2021

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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that air had been leaking from the fitting part of the aff valve and the cock when the tube was connected to the feeding set and pump.It was said that there was about 10cm of air bubbles occurring about five times while feeding 200cc.This caused discomfort to the patient due to stomach bloating so it had to be constantly monitored which was a hassle for the patient.The formula being used was enevo (50cc of which was diluted with 190cc of hot water) and solita-t granules no.3 (450g which was dissolved with 250cc of hot water).The duration of use was said to be about 10 minutes per formula.There was no other patient harm.

Manufacturer Narrative

Section b5 has been updated to include additional information provided on july 20, 2021.

Event Description

The customer reported that air had been leaking from the fitting part of the aff valve and the cock, when the tube was connected to the feeding set and pump.It was said that there was about 10cm of air bubbles occurring about five times while feeding 200cc.This caused discomfort to the patient due to stomach bloating so it had to be constantly monitored which was a hassle for the patient.The formula being used was enevo (50cc of which was diluted with 190cc of hot water) and solita-t granules no.3 (450g which was dissolved with 250cc of hot water).The duration of use was said to be about 10 minutes per formula.There was no other patient harm.Additional information provided on july 20, 2021 stated that a lot of air got mixed in the lower part of the pump set after a while but no air inclusion was observed in the upper part of the pump set.The customer had never experienced this before.

• Brand Name: J011RO JOEY ADAPUTER 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: 12189514
• MDR Text Key: 262245771
• Report Number: 8040459-2021-00562
• 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,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: J011RO
• Device Catalogue Number: J011RO
• Device Lot Number: 2035701FJY
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2021
• Patient Sequence Number: 1