MAUDE Adverse Event Report: CARDINAL HEALTH 18FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771810E
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported nursing hooked up a salem sump with multifunction port to wall suction and no suction occurred.Patient aspirated.Additional information received stated: placement of the tube was verified on an intubated patient.Tube feeds were being fed through this tube at a rate of 30ml/hr.They checked residuals at 0800.The residuals were 25ml.At 0900 when they laid the patient flat to turn (tube feeds were turned off at this time), the patient began to vomit around the ng/og tube.They promptly sat the patient up, grabbed a yankuer and put the ng/og to suction while suctioning the mouth and the patient's airway with the inline suction.The ng/og would not remove any contents from the the stomach.It would not sump correctly.The wall suction was working correctly, they tried intermittent suctioning and it was better but it wouldn't come down the tube.Wall suction was set at 80-120.They tried higher and lower.The cannister was intact as well.They also aspirated and flushed the ng/og with air but it would not sump.The patient vomited again around the tube.The customer originally stated the patient aspirated but in the additional information received from the customer they stated the patient was only at risk of aspiration.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.A sample evaluation could not be performed because no sample nor photo was available.Based on the present information, a possible root cause cannot be determined.The reported complaint could not be confirmed nor found related to the manufacturing process.No action plan is required at this point.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: 18FR SALEM W/ GIENTRI PORT WIT
• Common Device Name: 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: 15804217
• Report Number: 9612030-2022-03467
• Device Sequence Number: 14834788
• Product Code: PIF
• UDI-Device Identifier: 10884521582743
• UDI-Public: 10884521582743
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/21/2022

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: 7771810E
• Device Catalogue Number: 7771810E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/21/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown