MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN GASTRO INTESTINAL; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number UNKNOWN GI

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Perforation (2001)

Event Type  Injury  

Event Description

Per a post market clinical survey, the customer observed a perforation or hematoma of the esophagus, trachea, gastric tract, intestinal tract, or liver with the use of a salem sump.The customer stated there was a possible device relationship.This information was received via an anonymous post market clinical study; therefore, the customer information is unknown and no further information will be provided.

Manufacturer Narrative

This complaint was received via an anonymous clinical study.Sample analysis could not be performed since samples were not provided for evaluation.This complaint will be used for trending and post market analysis.

Manufacturer Narrative

Added an additional health effect - clinical code in section h6 for hematoma.

• Brand Name: UNKNOWN GASTRO INTESTINAL
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16469265
• MDR Text Key: 310534121
• Report Number: 9612030-2023-03593
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN GI
• Device Catalogue Number: UNKNOWN GI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1