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

Model Number J011RO

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the fluid leaked 12 hours after use.It was confirmed that there was a crack in the pump set.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample was received at the manufacturing site for evaluation without the original packaging.The sample was evaluated by visual inspection under micro zoom and the reported issue was confirmed, a leakage point was observed in the damaged silicone tubing.The root cause has been determined to be associated with the design of a tool being used by the supplier.An investigation completed by the supplier included a finite element analysis.The simulation results concluded that the material filled faster in the center six cavities, creating a backfill condition where the material flows into the other tubes that are filing slower.A new mold-flow analysis was conducted on the current tool used to understand it current state, as a result of the study it was confirmed that air bubbles were caused by the backflow effect.As part of continuous improvements, a corrective action has been opened to address the reported issue.The following actions have been taken to prevent a recurrence of the reported issue.The process router instructions have been updated, tooling modification and validation has been implemented, the product that was in-house has been evaluated, the use of a light table has been implemented to aide in the detection of air bubbles during inspection, a sort operator was added to the process to conduct a 100% in line inspection of the parts to screen for air bubbles before assembly, a quality alert was created to highlight the condition and bring awareness to operators, and both quality and production personnel were trained.In addition, the supplier has placed in-house product on hold for evaluation purposes.

• 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: 10173923
• MDR Text Key: 195742456
• Report Number: 8040459-2020-00531
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• 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: 1936137FJY
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2020
• Patient Sequence Number: 1