MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461043E

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Additional information has been requested but at this time, no further details have been provided.The complainant indicated that the device will not be returned 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 additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reports that the an iris tube was placed on a patient.The patient hemorrhaged and the patient expired.Additional information received from the assistant nurse manager of micu on (b)(6) 2019 stated that the patient was an (b)(6) male on heparin with swallowing issues and a lot of secretions.A ¿super user¿ tried to place the tube in one nare and hit resistance so tried the other nare.When trying the other nare they hit resistance 3 times and then decided to stop the placement.After this final attempt they noticed the patient bleeding.The patient had a dnr.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 8492548
• MDR Text Key: 141232152
• Report Number: 1282497-2019-08364
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR