inforMED
MalfunctionPIF

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

Model number

HP110126

Catalog 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.