MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP TUBE 8FR 24IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888268086
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
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 the feed was leaking from the ng tube into bed.The leaking was noted where the ng tube branches off at the reflux lumen on the tube.
Additional Manufacturer Narrative
The device history record (dhr) review showed no discrepancy.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.A walk through was performed and the manufacturing process was reviewed.All process 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 condition.In addition, quality control inspections are performed to the product for material release.Production personnel performs a 100% visual inspection during the packaging process, in order to detect and discard any identified issues.A risk assessment was performed to determine the occurrence of the reported failure mode.Based on the analysis, no further action is required.This complaint will be used for tracking and trending purposes.

• Brand Name: SALEM SUMP TUBE 8FR 24IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 14406981
• Report Number: 9612030-2022-03247
• Device Sequence Number: 14837533
• Product Code: KNT
• UDI-Device Identifier: 10884521007765
• UDI-Public: 10884521007765
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/06/2022

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: 8888268086
• Device Catalogue Number: 8888268086
• Device Lot Number: 2113134264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 06/06/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown