MAUDE Adverse Event Report: CARDINAL HEALTH ENFIT SALEM SUMP PVC TUBE 16FR 48IN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8888264960E

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

Patient Problem Internal Organ Perforation (1987)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that during surgery where the open abdomen receives a quantity of chemotherapy in liquid, the abdomen is subsequently closed and a salem nasogastric tube is installed to ensure drainage of gastric fluids.The tube would have created a perforation of the stomach wall because according to surgeons the tube would be too rigid.Additional information received on (b)(6) 2023 stated that the tube is 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.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.Sample was not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A root cause could not be determined.A corrective action is not applicable at this time.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: ENFIT SALEM SUMP PVC TUBE 16FR 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: 18052303
• MDR Text Key: 327125418
• Report Number: 9612030-2023-03849
• Device Sequence Number: 1
• Product Code: PIF
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888264960E
• Device Catalogue Number: 8888264960E
• Device Lot Number: 2305500264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2023
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other