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	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the rn was flushing the feeding tube, that was attached to the patient, with sterile water.By y-site location, at the port that has a tag attached "for enteral fluids only", the hard plastic part came apart from the rubber piece.There was no detectable damage, loose parts or broken pieces observed, but the plastic and rubber pieces would not stay sealed when attempting to put it together.Tape was used to hold the two pieces together since the two pieces appeared to easily come apart.There was no leaking at the site observed afterwards.Nurses assessed tubing at the bedside; recommending to leave the feeding tube in, as long as there is no leakage, and they reassess the need for replacement in the day time.The kangaroo feeding tube with iris technology was not used, due to patient refusal and was removed.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) is established based on the serial number stick on the device.There was no serial number provided by the customer, therefore the dhr could not be reviewed.The customer did not provide photographic evidence nor was the device returned for evaluation.Without a sample to evaluate, further evaluation is not possible and with limited information it is not possible to confirm where the plastic piece came apart from the rubber piece.The manufacturing process for the y-port assembly, test and inspection process was reviewed and a leak test would been accomplished according to customer specifications.The leak test would cover the kind of y-port issue as reported.The final inspection station requires that an inspector checks for a y-port issue.The manufacturing site confirmed that production personnel follow the specification and instruction.There are no corrective/preventative actions taken at this time.

• 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: 15214077
• Report Number: 1282497-2022-10714
• Device Sequence Number: 16671320
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG