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

Model Number	461243E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review is established based on the serial number stick on the device.The review could not be done because no serial number was available.The supplier confirmed from the lot number that production followed specifications and instructions.No sample was available for investigation so a root cause could not be determined.There is no action required at this time.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that the nasal gastric tube (ngt) is made of plastic that is not robust and it fell apart in their hands when attempting to administer medications.The tube must be replaced and therefore exposes the patient to unnecessary risk.Although this device reportedly lowers the risk of causing patient harm during insertion by utilizing iris camera technology, it is not robust enough to withstand repeated use and appears to have broken.The decreased risk associated with insertion of ng tubes with cameras is a moot point if the tube easily breaks and has to be reinserted.The probability of causing patient harm increases exponentially if the patient must undergo repeated insertions due to tubes breaking due to insufficient design.It is the belief of this rn that this design is not sufficient to withstand standard operation over a duration that most patients must tolerate, and therefore subjects the patients to increased risk of harm due to tubes having to be replaced due to breakage.

• 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: 16545195
• Report Number: 1282497-2023-10745
• Device Sequence Number: 12392321
• Product Code: KNT
• UDI-Device Identifier: 20884521742229
• UDI-Public: 20884521742229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 461243E
• Device Catalogue Number: 461243E
• Device Lot Number: 1243080122
• 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: 03/07/2023
• Initial Report FDA Received Date: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown