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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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
The customer reported that the blue suregrip was found to be detached from the tubing when the product was taken out of the individual package, there appeared to be a bonding failure.There was no patient injury.
Additional Manufacturer Narrative
Investigation summary: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.One sample without original package or lot number were received for evaluation.After performing a visual inspection, a detachment of the sure grip connector and missing solvent was observed.A gemba walkthrough the manufacturing area with the multifunctional team (quality, manufacturing, engineering) was conducted.After the walkthrough, an exact root cause could not be determined however a potential root cause 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 inspects the devices for the correct amount of adhesive.However, if the sensor has a variation then the issue of missing solvent may occur and be undetected.A work order was created to document the sensor settings.This complaint will be used for tracking and trending purposes.

• 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: 11400055
• Report Number: 9612030-2021-02804
• Device Sequence Number: 3372901
• 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): 04/26/2021

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: 8888301713
• Device Catalogue Number: 8888301713
• Device Lot Number: 2011502164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1