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	01/07/2020
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 the connector is not attached to the tubing.Additional information received on 09-jan-2020 stating that there were no other physical issue to the tubing or the packaging noted.Additional information received on 13-jan-2020 stated that both connectors were present which one detached.The issue was found when setting up for the case and not in the middle of the case.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed, and no discrepancies were found according to the failure mode reported.One unused sample with lot number 1927701964 was received for evaluation.The reported condition by the customer was observed; the connector was detached from the tubing.The connector was found with no signals of solvent which is required to be used by the operator during the assembly of the tube.The most likely root cause of the reported condition is due to a workmanship issue; the operator missed using solvent during the assembly process causing an inadequate assemble which ended in a detachment of the component.The failure mode reported by the customer was evaluated against the acceptable quality limit (aql).No action plan is deemed required since the complaint reported represents a defect rate of 0.02%, below the approved aql of 0.65%.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.

• 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: 9591749
• Report Number: 9612030-2020-02393
• Device Sequence Number: 16225228
• Product Code: GAZ
• UDI-Device Identifier: 20884527019653
• UDI-Public: 20884527019653
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 8888301614
• Device Catalogue Number: 8888301614
• Device Lot Number: 1927701964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1