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

Model Number	8888264986
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 3/15/2017.
Event or Problem Description
The customer reports the sump tube seemed to narrow or collapse when feeding.
Additional Manufacturer Narrative
One unused sample with lot number 633420364x was received for evaluation.After performing inspection functional per procedure, the condition reported was not confirmed.The device history record file was reviewed indicating that product was released meeting all quality standard requirements.The failure mode could not be confirmed.Therefore the root cause was not identified for this incident.Since the issue was not confirmed and no root cause was identified, no corrective actions are deemed necessary at this time.The current process is running according to product specifications meeting quality acceptance criteria.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SALEM SUMP
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur; no 125 cuidad; tijuana 92173 ; MX 92173
• MDR Report Key: 6405950
• Report Number: 9612030-2017-05033
• Device Sequence Number: 10958288
• Product Code: KNT
• UDI-Device Identifier: 20884521007731
• UDI-Public: 20884521007731
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 8888264986
• Device Catalogue Number: 8888264986
• Device Lot Number: 633420364X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability