MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461243E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Discomfort (2330)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that the tube broke at y junction.There was leaking observed when the feeding tube flushed after giving medication and with tube feeding running.No patient harm reported other than discomfort and inconvenience of replacing the feeding tube earlier than necessary.The feeding tube was placed on (b)(6) 2021.

Manufacturer Narrative

Section d4: lot number field has been updated, based on the additional information provided by the customer.

Manufacturer Narrative

A device history record review could not be performed because the serial number was not received with the complaint.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; 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: 11553396
• MDR Text Key: 241832173
• Report Number: 1282497-2021-09988
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2022

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
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Device Lot Number: 1255050120
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 03/16/2021; 03/16/2021
• Supplement Dates FDA Received: 03/26/2021; 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1