MAUDE Adverse Event Report: COVIDIEN J011RO JOEY ADAPUTER TYPE X30; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number J011RO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2020

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 there was a leak that occurred near the aff valve.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample has been received for the evaluation.The sample was evaluated by pumping test.Upon evaluation, leaking from aff valve was observed.Therefore, the reported condition is confirmed.Based on the evaluation, incomplete aff valve assembly from the supplier caused the product leakage.The supplier team has determined that the root cause could be because of the machine might not have been received right maintenance.The detection does not have a documented periodic inspection of the sensor.As a containment action, refresh training and establish visual control to operator who conduct 100% screen before assembly has been created.Full review of current status of pistons and sensors for the machines will be performed through maintenance orders.Analysis of means (anom) inspection is currently implemented along with quality inspection.

• Brand Name: J011RO JOEY ADAPUTER TYPE X30
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 9648000
• MDR Text Key: 177203892
• Report Number: 8040459-2020-00512
• Device Sequence Number: 1
• Product Code: KNT
• 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: 03/30/2020

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: J011RO
• Device Catalogue Number: J011RO
• Device Lot Number: 1911609FJY
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 03/30/2020
• Patient Sequence Number: 1