MAUDE Adverse Event Report: CARDINAL HEALTH ENFIT SALEM SUMP PVC TUBE 18FR 48IN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8888264986E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the tube was too rigid and did cause a gastric perforation; approximately 1-week post-installation, bile detected in abdominal drains.Upon surgical re-exploration, a perforation of the stomach was noted.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

The device history record review could not be performed since no lot number was provided.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: ENFIT SALEM SUMP PVC TUBE 18FR 48IN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 18066592
• MDR Text Key: 327302846
• Report Number: 9612030-2023-03852
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521779457
• UDI-Public: 10884521779457
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888264986E
• Device Catalogue Number: 8888264986E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other