MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP ANTI-REFLUX VALVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 1805086964

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2020

Event Type  malfunction  

Event Description

Multiple nurses have had issues with anti-reflux valves breaking.Nursing has to pull out broken pieces with hemostats or pliers from the ng tube.

• Brand Name: SALEM SUMP ANTI-REFLUX VALVE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy; fort mill SC 29707
• MDR Report Key: 9871612
• MDR Text Key: 184659817
• Report Number: 9871612
• Device Sequence Number: 1
• Product Code: FEG
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1805086964
• 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: 03/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1