MAUDE Adverse Event Report: CARDINAL HEALTH IRIS FEEDING TUBE 12FRX55 NS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461255
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the feed tubing was hanging on the floor leaking.Upon inspection, the iris dobhoff was found to be broken at the purple tube feeding port.The patient had just received medication via the medication port.It was reported to the rn that the port would leak when medications/flushes were administered.This was noted to have happened twice during the shift prior to the device breaking.No tugging on the tubing had occurred prior to the breakage, and it did not get caught on anything.
Additional Manufacturer Narrative
A device history record review could not be performed because the serial/lot 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.The physical device was not received for investigation.Because the device was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause of the event.If the device 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.

• Brand Name: IRIS FEEDING TUBE 12FRX55 NS
• 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: 15233909
• Report Number: 1282497-2022-10715
• Device Sequence Number: 12373684
• Product Code: KNT
• UDI-Device Identifier: 10884521165212
• UDI-Public: 10884521165212
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 461255
• Device Catalogue Number: 461255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/16/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 76 KG