MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC. SALEM SUMP ; DUAL LUMEN TUBE FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Catalog Number 8888266130

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

Event Date 02/16/2020

Event Type  malfunction  

Event Description

The anti reflux valve from the salem sump broke off and got stuck in the nasogastric tube.Two rns worked with hemostats to retrieve the valve; however, it crumbled into pieces as they tried to remove it.It appeared to be dry rotted.Eventually the rns was able to remove it from the ng tube completely without causing any pt harm.Fda safety report id# (b)(4).

• Brand Name: SALEM SUMP
• Type of Device: DUAL LUMEN TUBE FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC. ; mansfield MA 08048
• MDR Report Key: 9744700
• MDR Text Key: 180902003
• Report Number: MW5093212
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8888266130
• Device Lot Number: 1924101364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Weight: 50