MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR FEED TUBE 5 FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461503
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the purple end tip popped off from the inserted 5french 36 feeding tube being used on a baby for feeds.The tube was removed immediately with no known concerns to patient.Lot numbers that were available at the unit are lot #s 2231310564 or #2215831164.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section d4 - lot number: the lot number was updated per additional information provided by the customer on (b)(6) 2023.
Additional Manufacturer Narrative
The device history record file was reviewed, and no discrepancy was found according to the reported condition.The analyzed sample showed a detachment of the purple connector; in order to determine a root cause, a gemba walk was done at the manufacturing facility focusing on the manufacturing equipment and process; it was determined as a potential root cause was that the drying time was below specification.As corrective/preventative action, personnel production received an awareness notification of the reported complaint.

• Brand Name: POLYUR FEED TUBE 5 FR X 36
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 17326690
• Report Number: 9612030-2023-03761
• Device Sequence Number: 6658142
• Product Code: KNT
• UDI-Device Identifier: 20884521067971
• UDI-Public: 20884521067971
• 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,Followup
• Report Date (Section B): 11/09/2023

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: 461503
• Device Catalogue Number: 461503
• Device Lot Number: 2231310564
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/12/2023; 11/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown