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

Model Number 8888266197

Device Problems Break (1069); Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2021

Event Type  malfunction  

Event Description

Patient's nasogastric tube was capped using anti-reflux valve.When attempting to remove valve from capping the ng tube, it cracked and came apart with broken piece still in the ngt.Nursing eventually able to remove this broken piece from tip of ng so prevented need to remove ng tube altogether and replace.

• Brand Name: SALEM SUMP ANTI-REFLUX VALVE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street building 5; mansfield MA 02048
• MDR Report Key: 11292392
• MDR Text Key: 230689191
• Report Number: 11292392
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266197
• Device Catalogue Number: 8888266197
• Device Lot Number: 1932212564
• 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: 02/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1