MAUDE Adverse Event Report: MEDELA LLC ENTERAL FEEDING; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number ENPU2065

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

Patient Problem Insufficient Information (4580)

Event Date 02/12/2022

Event Type  malfunction  

Event Description

From 2/12/2022-3/4/2022, there were 13 reported nasogastric tubes that were noted to be cracked and leaking.This required the tubes to be placed.The affected lot#'s are: 211142; 210953; 211169.

• Brand Name: ENTERAL FEEDING
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr.; mchenry IL 60050
• MDR Report Key: 13860353
• MDR Text Key: 287685405
• Report Number: 13860353
• 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: 03/15/2022

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 Model Number: ENPU2065
• Device Lot Number: 211142, 210953, 211169
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Female