MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP ANTI-REFLUX VALVE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888266197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the blue end broke off the arv for seemingly no reason (per the staff nurse).
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because a lot number was not available.Pictures and one physical sample were received for evaluation.The image and sample were visually inspected, and a broken valve (arv) was observed.The reported condition was confirmed; however, it was not confirmed that the reported condition is related to manufacturing.A walk through or the manufacturing process was carried out showing no abnormal conditions that could trigger the reported condition.According to the instructions for use (ifu) included with product, the valve should be pulled out in the same direction of assembly and should not be pulled at an angle to avoid breaking.No action plan 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: SALEM SUMP ANTI-REFLUX VALVE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 19200778
• Report Number: 9612030-2024-00060
• Device Sequence Number: 8107230
• Product Code: KNT
• UDI-Device Identifier: 10884521007628
• UDI-Public: 10884521007628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/03/2024

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: 8888266197
• Device Catalogue Number: 8888266197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown