MAUDE Adverse Event Report: COVIDIEN SALEM SUMP ANTI-REFLUX VALVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888266197
Medical Device Problem Codes	Disconnection (1171); Inadequate User Interface (2958)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
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.
Event or Problem Description
The customer reported that the valves were broken in two when the staff tried to remove them from the patient¿s tube.While the patient was attached to suction, the valve prevents back flow of fluid through the air vent of the tube; the blue end of the valves sits on the blue air vent of the tube.When suction was not in use, the valve was used to ¿cap¿ the tube by inserting the white end of the valve into the drainage lumen tube.It¿s when the staff tried to pull the valve out of the drainage lumen to reconnect the patient to suction that the valve splits in two leaving the white portion plugged into the draining lumen.Additional information received on 10/01/2019 confirmed that the anti reflux valve failed to vent the stomach however there was no medical intervention required.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.One sample outside of the original package and missing a lot number was received for evaluation.After performing a visual inspection, the valve is visibly detached, and the complaint was confirmed.The most likely root cause indicates that this issue could occur during use if there are any deviations to the instructions of use (ifu).The ifu states: pull valve in the same direction of assembly.Do not pull at an angle to avoid breaking the valve.A review of the manufacturing process determined that product was manufactured in accordance with the official product specifications.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: SALEM SUMP ANTI-REFLUX VALVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9152804
• Report Number: 9612030-2019-02316
• Device Sequence Number: 2928902
• Product Code: KNT
• UDI-Device Identifier: 10884521007628
• UDI-Public: 10884521007628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/27/2019

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: 8888266197
• Device Catalogue Number: 8888266197
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1