MAUDE Adverse Event Report: NULL NUTRIPORT; GASTROINTESTINAL TUBE AND ACCESSORIES

Device Problem Material Rupture (1546)

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

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

Customer facility phone number: (b)(6).

Event Description

Information was received indicating that a smiths medical enteral tube's probe balloon broke after 13 days of use and needed to be replaced.There was no patient injury and no reported adverse events.

• Brand Name: NUTRIPORT
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section G): NULL
• MDR Report Key: 11901475
• MDR Text Key: 253177191
• Report Number: 3012307300-2021-05238
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1