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

Model Number 8888266130

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the device has been discarded.An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 287412737
• Report Number: 9612030-2022-03192
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• 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
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1