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	01/06/2021
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 sure grip (blue connector) on the tip of tubing came off at the start of use.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the device history record (dhr) was reviewed, and no discrepancies were found according to the condition reported.One unused sample with lot number 2005805764 was received for evaluation.After performing a visual inspection per our procedure, it was observed there was missing solvent.A gemba walk was made in the manufacturing area with the multifunctional team (quality, manufacturing, engineering).After this walk, it was determined that the 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 should inspect for the correct amount of adhesive.If this sensor has variations, missing solvent could occur.Based on the most likely root cause, a work order was registered to document the sensor settings.This change was made in (b)(6) 2020 after the manufacturing of the reported lot number.At this time, no further corrections are needed.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: 11147759
• Report Number: 9612030-2021-02744
• Device Sequence Number: 14320676
• 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): 03/11/2021

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: 2005805764
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 03/11/2021
• Patient Sequence Number: 1