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

Model Number 461503

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Section d4 - lot number: the lot number was updated per additional information provided by the customer on (b)(6) 2023.

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
• Type of Device: 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
• MDR Text Key: 319319544
• Report Number: 9612030-2023-03761
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521067971
• UDI-Public: 20884521067971
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1