MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC COVIDIEN NG TUBE WITH IRIS TECHNOLOGY; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number HP110126

Device Problems Break (1069); Structural Problem (2506)

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

Event Date 02/18/2023

Event Type  malfunction  

Event Description

Ngt is made of plastic that is not robust and fell apart in this rn's hands when attempting to administer medications.Tube must be replaced and therefore exposes patient to unnecessary risk related to replacement of ngt, including discomfort, possible trauma, death, pneumothorax, long length of stay, sepsis, pneumonia and other.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 patients to increased risk of harm due to tubes having to be replaced due to breakage.Therapy dates: (b)(6) 2023.

• Brand Name: COVIDIEN NG TUBE WITH IRIS TECHNOLOGY
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC
• MDR Report Key: 16437516
• MDR Text Key: 310331101
• Report Number: MW5115169
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2023

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 Operator: Health Professional
• Device Model Number: HP110126
• Device Catalogue Number: 461243E
• Device Lot Number: 1243080122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native