MAUDE Adverse Event Report: CARDINAL HEALTH 10FR 55 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461055E

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

The customer reported that the feeding tube was cracked.Per additional information received, the sample was removed from the patient and replaced.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Investigation summary: a sample was not returned for evaluation.The device history record (dhr) is established based on the serial number and lot number on the device however no serial number or lot number was provided by the customer, therefore the dhr could not be reviewed.Since no photos or samples were returned for evaluation, the reported issue was unable to be confirmed and the root cause could not be determined.During the manufacturing process, all tubes are 100% tested at an air leak test station which would fine an leaks.Devices can not be packaged if they fail the air leak test.The inspection station inspectors also check the tubes for cracks and perforated issues.Based on all available information, no abnormalities were found during the manufacturing process.The investigation was unable to confirm if the reported issue was related to the product itself or improper operation therefore no corrective actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 55 IRIS FEEDING TUBE ENF
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west st; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13667352
• MDR Text Key: 286573889
• Report Number: 1282497-2022-10680
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 93 KG