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

Model Number	8888264929
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant did not indicate that the device will be returned and there is no contact information available to request the sample from the customer for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If the sample is returned, the complaint will be re-evaluated.
Event or Problem Description
Customer reports that the patient needed an oral gastric tube (ogt) placed, not manufactured by covidien.This was approximately the 3rd ogt he has needed during his current hospital stay.The nurse was unable to get an ogt placed during day shift as it kept coiling in his mouth.The nurse obtained a 12 french covidien salem sump dual lumen stomach tube but was also unsuccessful for the same reason.The night nurse was then able to place the ogt easily without any issue or resistance and obtained an x-ray to confirm placement.The x-ray showed that the ogt was in the patient's lung and was removed without incident appearing intact upon removal.The patient required a bronchoscopy due to his illness and disease process.During the bronchoscopy, the physician found a 4cm piece of an ogt in patient's lung.It was removed without incident.

• 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: 6878651
• Report Number: 9612030-2017-05175
• Device Sequence Number: 13640979
• Product Code: KNT
• UDI-Device Identifier: 10884521007673
• UDI-Public: 10884521007673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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 Model Number: 8888264929
• Device Catalogue Number: 8888264929
• Device Lot Number: 529503964X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1