MAUDE Adverse Event Report: CARDINAL HEALTH 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 7771610E

Device Problem Suction Problem (2170)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) could not be performed because a lot number was not available.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Without a sample or photo, 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.In case of a repeated issues and/or recurrence, a new investigation for the specific events would be carried out for each case.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported, covidien salem sump tubing is used in the operating room for gastric suction in patients.On several occasions, the valve used for suction has failed, leaving patient secretions on the face and/or returning to the patients stomach.

Manufacturer Narrative

H6 health effect codes added per additional information received from the customer stating there was no patient harm.

• Brand Name: 16FR SALEM W/ GIENTRI PORT WIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 14013858
• MDR Text Key: 298306557
• Report Number: 9612030-2022-03204
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 10884521582736
• UDI-Public: 10884521582736
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7771610E
• Device Catalogue Number: 7771610E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1