MAUDE Adverse Event Report: CARDINAL HEALTH 12FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461243E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
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 that they were called to replace dht due to leaking.They arrived to find the tube feed line attached to the dht port.That port was cracked away from the main tube with only a small section of plastic holding it together.The tube feeding line was stuck in the hub and they were unable to disconnect it from the dhr.The old dht and bridle was removed and a new dht was placed.
Additional Manufacturer Narrative
A device history record review could not be performed because the serial and lot 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.There were no photos or physical sample returned for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.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.

• Brand Name: 12FR 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: 14977271
• Report Number: 1282497-2022-10704
• Device Sequence Number: 5098362
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Unknown