MAUDE Adverse Event Report: COVIDIEN N-C CONN TUBE 6MM X3.1M; TUBING, NONINVASIVE

Model Number	8888301614
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
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 is not attached and the transparent connector is missing in the package.The issue was found before use.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The product was manufactured on february 19, 2020.One unused sample with lot number 2004402064 was received at the manufacturing site on november 19, 2020 for evaluation.A visual evaluation was performed, and the reported issue of the missing transparent connector could not be confirmed as the connector was present in the sample received.However, the reported issue of the blue connector not being attached was confirmed.A gemba walk was completed in the manufacturing area with the multifunctional team (quality, manufacturing, engineering); and it was determined that the potential root cause of the blue connector not being attached could be due to missing adhesive resulting from a variation in the sensor that detects and alarms the system.When the application of adhesive is performed the sensor should be inspecting for the correct amount of adhesive, if this sensor has variation thee reported issue could occur.As part of continuous improvements, a work order was registered to check the sensors that detect the solvent to ensure it alarms if solvent is not injected.This action was designed to prevent the reoccurrence of the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 6MM 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: 10722083
• Report Number: 9612030-2020-02672
• Device Sequence Number: 3125355
• Product Code: GAZ
• UDI-Device Identifier: 20884527019653
• UDI-Public: 20884527019653
• 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): 02/05/2021

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: 8888301614
• Device Catalogue Number: 8888301614
• Device Lot Number: 2004402064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1