MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 14FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884715148E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
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 product broke below the connection site.There was no patient inquiry.Per additional information provided on may 31, 2023, a portion of the y-port broke off/fully detached.The tube was replaced to resolve the issue.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 12-feb-2023.A picture of the catalog was provided for analysis.Based on the information available to us, we were unable to confirm the reported issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information received from the customer.Section h6 (medical device problem code) has been updated to include 1250- fluid leak, based on the additional information received.Aware date: originally reported as (b)(6) 2023 and should be (b)(6) 2023.
Event or Problem Description
The customer reported the product broke below the connection site.There was no patient injury.Per additional information provided by the customer on (b)(6), 2023, a portion of the y-port broke off/fully detached.The tube was replaced to resolve the issue.Per additional information received from the customer on (b)(6) 2023, the piece was completely detached and was moving freely in/out, leaking.The staff was unable to unscrew the formula tubing from the port.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 17050639
• Report Number: 9612030-2023-03713
• Device Sequence Number: 3479682
• Product Code: PIF
• UDI-Device Identifier: 10884521661639
• UDI-Public: 10884521661639
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 09/05/2023

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: 8884715148E
• Device Catalogue Number: 8884715148E
• Device Lot Number: 2302313564
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 05/30/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/15/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown