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

Model Number 461055E

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the port disconnected from the tube.There was no patient harm reported.

Manufacturer Narrative

A device history record review could not be performed because the serial number was 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.One physical sample was received at our decontamination lab.However, the used sample could not be forwarded to the manufacturing site for physical evaluation due to current customs policies.As a result, photos were instead taken of the sample by the decontamination lab and provided to the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue of port disconnected from the tube issue was not observed.Therefore, the root cause of the detached component could not be determined at this time; however, a y-port crack was observed.If the y-port was cracked in original package, it cannot be used by a doctor.Therefore, the crack could have occurred during use by an external force.The actual root cause of the y-port crack could not be determined.If additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.The manufacturing process of the y-port assembly, test, and inspection was reviewed and found that all tubes have been 100% tested and inspected.A corrective action is not applicable 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 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: 16234914
• MDR Text Key: 308355762
• Report Number: 1282497-2023-10727
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: 461055E
• Device Catalogue Number: 461055E
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/14/2023
• 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