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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that there was an issue with one of the nasogastric (ng) tubes that was in use on a patient.After being put into use it was found to be cracked and led to complications.The staff believes that the patient may have just bit/chewed at some point.None of the other units checked had any issues.Additional information was received and stated that a crack (a small slit) was found in the tube approximately at the measurement of 65 and there was no detachment observed.They were not sure if the tube was cracked due to patient bit/chewed the tube.Due to the crack, slow trickle of leaking of the tube feeding was observed into the mouth.Thus, suctioning out of the mouth secretions that lead to stopping the tube feeding due to what was perceived to be intolerance.The tube was removed and replaced with another tube.Per medical staff, they were unable to assess the details of medical intervention/treatment provided to the patient involved.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 20-may-2022.A sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• 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; 777 west street; 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: 15815159
• Report Number: 9612030-2022-03468
• Device Sequence Number: 7074183
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: 10884521004719
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/05/2023

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
• Device Lot Number: 2213034264
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown