MAUDE Adverse Event Report: COVIDIEN N-C CONN TUBE 7MM X3.1M; TUBING, NONINVASIVE

Model Number	8888301713
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2019
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 blue connector came off when they tried to use it.It was noticed before use.No patient involved.
Additional Manufacturer Narrative
The device history record file was reviewed and no discrepancies were found according to the failure mode reported.Four pictures and one decontaminated sample without original package or lot number was received for evaluation.After performing visual inspection based on our procedures the reported issue was confirmed; missing solvent can be observed in the tube.A gemba walk was performed at the manufacturing area with the multifunctional team (quality, manufacturing, engineering).After this gemba walk the specific root cause could not be found.The current process was running according to approved specifications.A probable root cause could be that at the time of manufacturing, the station sensor was not adjusted.Based on the most probable root cause for the condition reported, a maintenance order was created to address this root cause on january 13, 2020.With this maintenance order control boxes are installed for protection of the optical fiber modules and sensors to avoid damage and bad adjustments.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: N-C CONN TUBE 7MM X3.1M
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9304402
• Report Number: 9612030-2019-02349
• Device Sequence Number: 19340647
• Product Code: GAZ
• UDI-Device Identifier: 10884527019700
• UDI-Public: 10884527019700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 8888301713
• Device Catalogue Number: 8888301713
• Device Lot Number: 1826814264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/23/2020
• Patient Sequence Number: 1