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

Model Number	8888266197
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the device will not be returned for evaluation because it has been discarded.
Event or Problem Description
Customer reports: the salem sump connector between the nasogastric tube and the suction tubing broke in half when the bedside nurse attempted to reconnect the suction after it had been clamped off.She pulled the piece out of the end of the nasogastric tube and it broke leaving the blue half of the device lodged inside the nasal gastric tube (ngt).Staff were able to remove the connector from the tube.Afterward, were able to resume suction.Impact of incident: the patient was frustrated as we were unable to initiate the suction for some time until it was problem solved.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further 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; 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: 18650819
• Report Number: 9612030-2024-00034
• Device Sequence Number: 12823241
• 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): 02/23/2024

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
• Device Lot Number: 2313101564
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown