MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR FEED TUBE 6.5FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461420
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the port of the feeding tube was disconnecting from the tube and there was leaking.The tube was removed and saved.Afterward, the port separated from the tube completely.The tube was swapped out for a new tube which worked without issue.
Additional Manufacturer Narrative
H3: evaluation summary: the device history record (dhr) review could not be performed because no lot number was available.One sample with an unknown lot number was received for evaluation at the manufacturing site.After performing a visual inspection, the separation of the purple connector can be observed.The reported condition was confirmed.A walk through was performed at the manufacturing area with the multifunctional team.The specific root cause could not be determined.The current process is running according to approved specifications.Based on the analysis, the rate of occurrence is equal/below the expected range.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 6.5FR X 20
• 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: 13773693
• Report Number: 9612030-2022-03191
• Device Sequence Number: 17070617
• Product Code: KNT
• UDI-Device Identifier: 10884521067936
• UDI-Public: 10884521067936
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/29/2022

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: 461420
• Device Catalogue Number: 461420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/29/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown