MAUDE Adverse Event Report: DALE MEDICAL PRODUCTS, INC DALE ENFIT ACE CONNECTOR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 485

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Vomiting (2144)

Event Date 12/30/2019

Event Type  malfunction  

Event Description

Patient was on sedation holiday, gag on endogastric (et) and orogastric (og) tube.Vomited around et tube.Had tube feedings running, which were stopped immediately.Attempted to remove dale with enfit connection in order to hook patient up to suctioning however, unable to do so.Connector was stuck for several minutes.Then wall suction did not work once connector was removed.Use of dale connector with legacy connection would have been able to transition from feeding to suction faster and more efficiently.

• Brand Name: DALE ENFIT ACE CONNECTOR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): DALE MEDICAL PRODUCTS, INC; 40 kenwood circle suite 7; franklin MA 02038
• MDR Report Key: 9585974
• MDR Text Key: 174879402
• Report Number: 9585974
• 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: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 485
• Device Catalogue Number: 485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1