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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the connector cracked during use after several months causing the feeding tube to leak formula.As a result, the feeding tube was replaced prematurely.There was no patient injury and there was no delay to treatment because of the intervention.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.The device was received for evaluation.The returned device had damage to the connector (y-port), which was observed to be broken at the y-union.During the investigation, a review of the manufacturing process was conducted, and all process and controls were found properly followed, including sub-assemblies and finished product assembly and packaging.There were no abnormal conditions found that would have caused or contributed to the reported condition.As part of the investigation review activities, we did initiate a corrective and preventive action (capa) to investigate and determine appropriate corrective and preventive actions, which resulted in a design related improvement to strengthen the y-port and y-port connections.
Additional Manufacturer Narrative
Appropriate term/code not available in h6: scabs section b3 has been corrected.
Event or Problem Description
The customer reported that the connector cracked during use after several months causing the feeding tube to leak formula.As a result, the feeding tube was replaced prematurely.There was no patient injury and there was no delay to treatment because of the intervention.Additional information received on december 31, 2021 stated that on (b)(6) 2021, a nurse had noticed that one of the two tips of the tubing was broken so it was decided to put the feeding on the second tip.On (b)(6) 2021, a dressing was put on the enfit connector of the two administration sites.The administration site had remained broken since (b)(6) 2021 and was ready to be detached from the tubing.The pge showed feeding and some scabs with feeding around it.Dressings were done again and it was noted that the tubing would be changed.On (b)(6) 2021, there were bilious flows at the pge site.On (b)(6) 2021 there was a leak at the pge after enteral hydration via pge.On (b)(6) 2021, the tubing was removed and exchanged by another tubing from another manufacturer.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 12750978
• Report Number: 9612030-2021-03076
• Device Sequence Number: 4549994
• Product Code: PIF
• UDI-Device Identifier: 10884521661639
• UDI-Public: 10884521661639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/08/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 11/04/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/13/2022; 03/08/2022
• 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