MAUDE Adverse Event Report: COVIDIEN 10FR X 55" ENTRIFLEX W/STYLET; FEEDING TUBE

Model Number 8884721055

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Death (1802); Fever (1858); Pneumonia (2011); No Code Available (3191)

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2014 that a pt had an adverse event while the feeding tube was in place.The customer states that a (b)(6) male pt was hospitalized in the icu on (b)(6) 2013 where he remained for 2 weeks and received intravenous antibiotic treatment.According to the peg/j procedure, the naso-intestinal tube was placed endoscopically.The symptoms anorexia and fever presented on the same day ((b)(6) 2013) as the aspiration pneumonia was diagnosed.In (b)(6) 2013 the pt died, cause of death was reported as aspiration pneumonia.The treating neurologist clarified that the aspiration pneumonia is not related to duodopa or the nj tubing.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: 10FR X 55" ENTRIFLEX W/STYLET
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana 92173 ; MX 92173
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana 9217 3; MX 92173
• Manufacturer Contact: elaine bishop ; 15 hampshire st; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3779508
• MDR Text Key: 4444961
• Report Number: 9612030-2014-00024
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/11/2014

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
• Device Operator: Health Professional
• Device Model Number: 8884721055
• Device Catalogue Number: 8884721055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR