MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP W/ARV 18 FR CE/INTL; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	266148
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that when using the tube, the tip gets stuck in the catheter and possibility of closing or gently suctioning the catheter.Additional information was received and stated that repeated connection/disconnection of the valve was the source of the valve break problem.There was no harm reported.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.A physical sample was not received for the investigation; however, a picture was provided for evaluation.Upon reviewing the picture, the reported issue was confirmed.Because a physical sample was not returned, we were unable to determine the definitive root cause of the reported issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: SALEM SUMP W/ARV 18 FR CE/INTL
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19524671
• Report Number: 1423537-2024-00033
• Device Sequence Number: 15538199
• Product Code: FEG
• UDI-Device Identifier: 10884521065055
• UDI-Public: 10884521065055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 266148
• Device Catalogue Number: 266148
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/25/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown