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

Model Number	264929
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had air leakage at the probe junction and the pipe used to seal the probe junction.Status of patient outcome was unknown.
Additional Manufacturer Narrative
The device history record file was reviewed indicating that product was released meeting all quality standard requirements.One unused sample was received for evaluation.The sample received was tested in order to determine the root cause; however, there were no issues found.The reported issue could not be confirmed.A root cause could not be determined.A corrective action is not deemed necessary at this time.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. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 6969756
• Report Number: 9612030-2017-05217
• Device Sequence Number: 13469586
• Product Code: KNT
• UDI-Device Identifier: 10884521067196
• UDI-Public: 10884521067196
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/08/2018

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: 06/30/2020
• Device Model Number: 264929
• Device Catalogue Number: 264929
• Device Lot Number: 515308664X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1