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

Model Number	461043E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A device history record review could not be performed because the lot and serial numbers were not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A sample was not received for investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations and we are not able to determine the relationship between this device and the cause of the event.According to the customer's report, it seems that the problem was not caused by the product itself.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that the patient had an iris tube placed into the lung resulting in a pneumothorax.The rn removed the feeding tube and tried to place the tube again.The patient died from the injury.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 15160266
• Report Number: 1282497-2022-10710
• Device Sequence Number: 6167336
• Product Code: KNT
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 08/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown