MAUDE Adverse Event Report: COVIDIEN 10FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded; 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The initial reporter stated that the patient had an nj tube placed on (b)(6) 2019.On the 2nd postprocedural day/3rd titration day the patient had five diarrheal vacuolations and tensile fever (37.3°c/99.14° f).In addition, the patient required an oxygen mask and was examined by a pathologist and found to have an infection.On the 3rd postprocedural day/4th titration day the fever receded.The diarrheal outbreaks stopped.The treating physician diagnosed the patient with a respiratory infection and reported that the patient is doing better and was scheduled for discharge on (b)(6) 2019.

• Brand Name: 10FR X 55 ENTRIFLEX W/STYLET
• 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: 9129989
• Report Number: 9612030-2019-02302
• Device Sequence Number: 14031668
• Product Code: KNT
• UDI-Device Identifier: 10884521518865
• UDI-Public: 10884521518865
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 8884721055
• Device Catalogue Number: 8884721055
• Device Lot Number: 509780964X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 75