MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720221E

Device Problem Unintended Deflation (4061)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during the nursing round, there was evidence of a displaced gastrostomy probe and burst balloon.The chief and doctor on duty were informed, who assessed the patient.

Event Description

The customer reported that during the nursing round, there was evidence of a displaced gastrostomy probe and burst balloon.The chief and doctor on duty were informed, who assessed the patient.On (b)(6) 2023 it was stated that it was necessary to place another tube or gastrostomy tube.

Manufacturer Narrative

Updated b5 event description and h6 health effect - impact code based on additional information received.Investigation summary: the physical sample was not returned for evaluation.Instead a photo and video was provided for review.Per review of the photo, a broken balloon was observed.In the video a completely burst balloon, without detachment in the upper side of the balloon, was observed.A gemba was carried out in the manufacturing process.The current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.A root cause could not be determined based on the information available.A corrective and preventive action was opened with the supplier to address the issue through a more robust investigation.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; 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: 16967750
• MDR Text Key: 315654316
• Report Number: 9612030-2023-03705
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720221E
• Device Catalogue Number: 8884720221E
• Device Lot Number: 2231317964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 77 YR