MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP W/ ARV 16FR. 48IN; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266130
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the device has been discarded.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: after inserting the tube into the patient the nurse noticed that it was not placed properly.When they tried to remove the tube they were unable to because it was stuck and inflicting pain on the patient.They cut the tube and removed some through the mouth and the rest through the nose.The tube somehow knotted itself while it was being inserted.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided from customer complaint report, and no photo sample/actual sample with an identifiable lot number was received.The complaint report indicates that no sample is available in connection with this complaint report however, two photographs were submitted for review and investigation.After a visual inspection of the photos, it appears that there is a knot in the catheter.A gemba walk through was conducted in the manufacturing area with the multifunctional team (quality, manufacturing, engineering); it was determined that the potential root cause could not have happened in the manufacturing floor as there is no step in the manufacturing process in which the product is handled to the point of knotting the device.A visual inspection is performed before the release of the product with acceptable results.Based on the analysis, the observed occurrence of harm improbable which is below the range of the expected occurrence rate therefore corrective actions are not deemed necessary at this time.

• Brand Name: SALEM SUMP W/ ARV 16FR. 48IN
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 13803950
• Report Number: 9612030-2022-03192
• Device Sequence Number: 20091863
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 8888266130
• Device Catalogue Number: 8888266130
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown