MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 14FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715148E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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 because of the overhang in a new feeding system, it is screwed down very tightly and is almost impossible to loosen.The kocher is tried and therefore quick breakage of the piece.No injuries occurred.Per additional information provided on 30-jun-2022, when changing the feed line, they don't get the screw cap open, so they have to put force on it and use kocher forceps to try to loosen it.However, this doesn't work and a crack appears in the y part of the y-port causing a leak.They use powdered milk which goes through the feed line, they themselves think it is because of the sugar that the twist cap no longer opens due to the hardening of the sugar.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on october 07, 2021.A physical sample was not received for the investigation, but a video was provided.The video was inspected, and the reported issue was confirmed.A corrective and preventative action has been initiated to address the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 14918218
• Report Number: 9612030-2022-03304
• Device Sequence Number: 6175850
• Product Code: KNT
• UDI-Device Identifier: 10884521661639
• UDI-Public: 10884521661639
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/11/2022

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: 8884715148E
• Device Catalogue Number: 8884715148E
• Device Lot Number: 2127008964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/11/2022
• 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