MAUDE Adverse Event Report: CARDINAL HEALTH TUBE SALEM SUMP SIL 5IN1 16FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888265132
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: an ng tube was placed by nursing on a patient care unit.The nurse noted that the ng tube had no output when placed to suction and they were unable to flush the tube.The service placed an order to reposition the tube.The nurse was still unable to flush the tube after repositioning, and the ng tube was removed.Once removed the nurse noted that the tube was defective.There were no holes or vents at the bottom of the tube.
Additional Manufacturer Narrative
Additional information was received on 5/4/22 therefore the following fields have been updated: section b3: describe event or problem - additional information added.Section h6: health effect - clinical code initially updated from code 4582 to code 2330.Section h6: health effect - impact code initially was updated from code 2199 to code # 4629.
Event or Problem Description
Additional information received on 5/4/22, the patient experienced discomfort and required medical intervention to replace the device.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.The product sample was not provided for evaluation therefore the reported condition could not be confirmed.The root cause and corrective actions could not be identified without a sample evaluation.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: TUBE SALEM SUMP SIL 5IN1 16FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14287150
• Report Number: 1282497-2022-10687
• Device Sequence Number: 1519721
• Product Code: KNT
• UDI-Device Identifier: 10884521020092
• UDI-Public: 10884521020092
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2022

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: 8888265132
• Device Catalogue Number: 8888265132
• Device Lot Number: 212290001
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 05/03/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/09/2022; 05/31/2022
• 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