MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP; 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	01/10/2025
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 anti reflux valve used for ng tubes are noted to be more fragile and breaking apart.This has been noted on multiple units.The valves become wedged in the blue tubing of the ngs and are almost impossible to replace when they break at the weak point (just below the disk at the midpoint).
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure mode.¿ as such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported the anti-reflux valve (arv) used for ng tubes are noted to be more fragile and breaking apart.This has been noted on multiple units.The valves become wedged in the blue tubing of the ngs and are almost impossible to replace when they break at the weak point (just below the disk at the midpoint).Per additional information provided by the reporter on 27jan2025, the arvs were removed from the ng tubes and replaced with a new arv.Once the valve breaks it is incredibly difficult to remove and replace the broken valve, staff has to cut the blue tubing in order to attach a new valve.

• Brand Name: SALEM SUMP
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 21168177
• Report Number: 1423537-2025-00035
• Device Sequence Number: 9475264
• Product Code: KNT
• UDI-Device Identifier: 10192253012866
• UDI-Public: (01)10192253012866
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K851444
• 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): 01/27/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/27/2025
• 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