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

Model Number	266130
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	12/18/2021
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 states that the patient experienced mesenthereal ischemia and had a blocked stomach.As a result, the tube was placed for suction and placement was confirmed by the surgeon.The patient experienced episodes of vomiting and it was discovered that there were no holes at the end of the tubing.There was no suction provided through the tube.There was no medical intervention required and no patient injury.The tube was replaced.
Additional Manufacturer Narrative
There were no physical samples or photos received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.No discrepancies were found relating to the issue reported.Since no samples or photos were received for evaluation, the issue reported could not be confirmed.The manufacturing process was reviewed; all processes and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported issue.Furthermore, there have been no similar problems detected in our manufacturing process for this failure.At this time, no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.If a sample is received at a later date, this complaint will be reopened for further investigation.We will keep monitoring the process for any adverse trends that require immediate attention.
Additional Manufacturer Narrative
The device history record (dhr) for the reported lot number (2010002064) was reviewed, and no discrepancy was found according to the failure mode reported.A catheter and pouch with lot number 2010002064 was received for evaluation.After performing a visual inspection, the catheter received does not correspond to the product code reported.Furthermore, the catheter received is not recognized as a cardinal health device therefore no further device analysis could be completed, and the reported condition could not be confirmed.No action plan is deemed required at this time.The current process is running according to product specifications meeting quality acceptance criteria.If additional information or the actual sample is received at a later date, the investigation will be updated accordingly.This complaint will be used for tracking and trending purpose.

• Brand Name: SALEM SUMP W/ARV 16 FR CE/INTL
• 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: 13155315
• Report Number: 9612030-2022-03131
• Device Sequence Number: 11791779
• Product Code: FEG
• UDI-Device Identifier: 10884521065031
• UDI-Public: 10884521065031
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• 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,Followup
• Report Date (Section B): 04/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 266130
• Device Catalogue Number: 266130
• Device Lot Number: 2010002064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 12/20/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/09/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown