MAUDE Adverse Event Report: UNKNOWN NASO GASTRIC TUBE; TUBE, NASOGASTRIC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Laceration(s) (1946)

Event Date 03/14/2022

Event Type  Injury  

Event Description

Had fourth nasogastric tube placed.Tube did not work, went to urgent care at (b)(6)cancer center, which inserted tube.Left at 2 am after waiting for hours.Patient not able to be given nutritional sustenance that day.Had to have tube inserted directly into stomach.Fda safety report id #(b)(4).

• Brand Name: NASO GASTRIC TUBE
• Type of Device: TUBE, NASOGASTRIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15322363
• MDR Text Key: 299033540
• Report Number: MW5111806
• Device Sequence Number: 4
• Product Code: BSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male