MAUDE Adverse Event Report: COVIDIEN MICROBORE EXTENSION SET 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	60ES
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the infant was being placed back in isolette after doing skin to skin with the infant on the mattress and the purple capped tip of the microbore extension set separated.The extension set was promptly disconnected and replaced.There were no additional treatments required other than replacing the extension set.There was no patient injury.
Additional Manufacturer Narrative
The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One sample was received at the manufacturing site for evaluation.The sample arrived in the original packaging with multiple cuts to the tube.The sample was evaluated, and the reported issue could not be confirmed.A root cause could not be determined as the reported issue was not confirmed.During the investigation the multidisciplinary team performed a gemba walk.The manufacturing process, workstations, tools and fixtures were reviewed to verify if anomalies or conditions may cause the condition reported, but no findings were detected.Based on the information available it has been determined that the product was manufactured according to current product specification and was tested under the current acceptance criteria.Corrective action will be limited to manufacturing awareness this time.The current process is running according to product specifications meeting quality acceptance criteria.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MICROBORE EXTENSION SET 60IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10049182
• Report Number: 9612030-2020-02465
• Device Sequence Number: 14165168
• Product Code: KNT
• UDI-Device Identifier: 20884521143910
• UDI-Public: 20884521143910
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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
• Operator of Device: No Information
• Device Model Number: 60ES
• Device Catalogue Number: 60ES
• Device Lot Number: 1921815564
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1