MAUDE Adverse Event Report:; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

Gastric tube (gt) dressing removed for gt site cares, gt dislodged from abdomen, balloon discovered to be faulty.Resecured with tape, icu doctor to bedside to assess, nurse consulted and instructed to replace gt with same size and resume feeds/meds.Gt initially saved with plan to be sent down to be checked by products but nursing was instructed that no tubes should be saved at this time due to covid and should just be thrown out.Tube was discarded.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 10091472
• MDR Text Key: 192162448
• Report Number: 10091472
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Date Report to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 210 DA