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

(b)(6).

Event Description

Information was received indicating that a smiths medical enteral feeding tube's internal balloon burst and the material had to be replaced.The customer further stated that the gastrostomy button was implanted in the patient following all the manufacturer's recommendations, however, one day after implantation, the patient's mother noticed that the device was coming out of the stoma showing that the balloon of the device was ruptured.No patient injury was reported.There were no reported adverse events.

• Brand Name: NUTRIPORT
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section G): NULL
• MDR Report Key: 11901190
• MDR Text Key: 253162991
• Report Number: 3012307300-2021-05233
• 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

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• 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: Initial
• Patient Sequence Number: 1