MAUDE Adverse Event Report: COVIDIEN SUCTION TUBE 6MM X 3.7M / 1/4; TUBING, NONINVASIVE

Model Number	5558301627
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/02/2020
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 end of the suction tubing fell off.This happened before use, during prep.
Additional Manufacturer Narrative
The device history record files were reviewed and no discrepancies were found relating to the issue reported.One decontaminated sample without original package or lot number was received for evaluation.After performing a visual inspection per our procedure the connector was found to not have adhesive on one side of the connecting tube.The most probable root cause is due to a workmanship issue; the operator is responsible for assembling the tube with the connector as well as discarding any component that does not meet specification therefore the reported issue is generated when the operator fails to ensure that the component is acceptable.The personnel team was notified and made aware of this complaint.The failure was evaluated against the acceptable quality limit (aql) and based on all available information, no additional actions are deemed required at this time; the issue reported is below the approved aql and no trend exists.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: SUCTION TUBE 6MM X 3.7M / 1/4
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10315776
• Report Number: 9612030-2020-02542
• Device Sequence Number: 14309447
• Product Code: GAZ
• UDI-Device Identifier: 10884527019298
• UDI-Public: 10884527019298
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 5558301627
• Device Catalogue Number: 5558301627
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1