MAUDE Adverse Event Report: CARDINAL HEALTH 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461043E
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Death
Event or Problem Description
The customer reported the iris tubing was misplaced in the airway due to heavy secretion.They could not confirm via visualization.The radiologist and staff via fluro missed misplaced tube due to other og (oral gastric) tube placed in stomach.Medication/nutrition was administered.Additional information received stated the patient passed away but at this time it is unknown if the device was related to the patient¿s death.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review was unable to be performed because a lot or serial number was not available.No sample and no photos were provided for evaluation.A root cause could not be determined.The supplier confirmed the production followed the specifications and instructions.No action will be taken at this moment.If additional information or a sample is provided, this investigation will be updated as necessary.No corrective action is required based on the investigation result.This complaint will be used for tracking and trending purposes.H6 medical device problem code.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: 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: 13893216
• Report Number: 1282497-2022-10682
• Device Sequence Number: 6441878
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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 Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/06/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown