COVIDIEN NG TUBE WITH IRIS TECHNOLOGY
Received Feb 23, 2023 · Event occurred Feb 18, 2023
Report MW5115169 · MDR key 16437516
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Covidien / Cardinal Health 200, LlcModel number
HP110126Catalog number
461243E
Lot number
1243080122
Product problems
- Break
- Structural Problem
Patient
25 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.