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

Model Number	8888301721
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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
Customer reports: before use, two of the sure grip part of the tubing fell off.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on june 21, 2020.One suction tube with lot number 2016826964 was received at the manufacturing site for evaluation.A visual inspection was performed, and the reported issue was confirmed; the sure grip connecter was found to be detached and missing solvent was observed.A gemba walk was performed in the manufacturing area with the multifunctional team (quality, manufacturing, and engineering); and it was determined that the potential root cause for the missing adhesive causing the reported issue was due to a variation in the sensor that detects and alarms the system.When the application of adhesive is performed, the sensor inspects for the correct amount of adhesive.If this sensor has variation, then missing solvent could occur.Based on the most probable root cause, the failure mode originated during the automatic assembly process.The current assembly process is done manually and there is no evidence of solvent application failure at this time in the current process.If the process returns to an automatic assembly, a confirmation run of the process conditions will be carried out.A corrective action is not applicable at this time as the process has been changed.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: N-C CONN TUBE 7MM X3.7M
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11812311
• Report Number: 9612030-2021-02893
• Device Sequence Number: 1388312
• Product Code: GAZ
• UDI-Device Identifier: 10884527019717
• UDI-Public: 10884527019717
• 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): 08/20/2021

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: 8888301721
• Device Catalogue Number: 8888301721
• Device Lot Number: 2016826964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/20/2021
• Patient Sequence Number: 1