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 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the nursing round was performed and the patient was assisted in changing of position, skin lubrication, and protection of bony prominences.The shift leader noticed the exit of the gastrostomy probe and a broken balloon was observed.Nelaton probe posture was performed.The physician on duty of the qx general service was informed who referred to enlist everything for passage of a new one.The shift manager was informed.The patient continues under safety and comfort measures.

Manufacturer Narrative

The device history record file was reviewed.No discrepancies were found according to the reported issue.The physical sample was not returned for evaluation however, a photo and video were provided for reference.After performing a visual inspection of the photo and video, a ruptured balloon was observed.A gemba was carried out in the manufacturing process.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.A supplier corrective action request has been initiated to address the reported issue.

• 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 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: 16966749
• MDR Text Key: 315690750
• Report Number: 9612030-2023-03704
• 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,Company Representative,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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: 2233328464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Date Device Manufactured: 12/02/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 42 YR