MAUDE Adverse Event Report: MEDELA LLC NASOGASTRIC TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 211064

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Nasogastric tube was cracked where feeding tubing connects.Infants feed was leaking out of crack.Infant lost part of feed and needed another nasogastric tube placed.

• Brand Name: NASOGASTRIC TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• MDR Report Key: 13659251
• MDR Text Key: 286514230
• Report Number: 13659251
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 211064
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 DA