MAUDE Adverse Event Report: CARDINAL HEALTH PORT GIENTRI 12FR SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	7771210
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the patient had the device in under intermittent suction.The suction was increased to over 400mm/hg with little result.The product was pulled, an og (oral gastric tube) was placed, and a substantial volume of gastric contents were pulled.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.A sample analysis could not be performed because no photo or sample was received.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Based on the present information, and because no photo or sample was received, the root cause could not be determined.No action plan could be performed.The current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing site will continue to monitor the process, customer complaints, and feedback notifications for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: PORT GIENTRI 12FR SALEM SUMP
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13618997
• Report Number: 9612030-2022-03182
• Device Sequence Number: 4368671
• Product Code: FEG
• UDI-Device Identifier: 10884521004368
• UDI-Public: 10884521004368
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7771210
• Device Catalogue Number: 7771210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/11/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown