MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461243E

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

Patient Problems Erosion (1750); Septic Shock (2068)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) is established based on serial number however a serial number was not provided therefore the dhr was unable to be reviewed.A lot number was provided however the lot does not correspond with the dhr.No samples were received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported the covidien kangaroo feeding tube with iris technology eroded through the patient's stomach and transverse colon causing septic shock and need for emergent surgery.No additional information is available.

• Brand Name: 12FR 43 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14702290
• MDR Text Key: 294141015
• Report Number: 1282497-2022-10695
• Device Sequence Number: 1
• Product Code: PIF
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Device Lot Number: 1243090120
• Date Manufacturer Received: 06/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1