MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884715122

Device Problem Material Perforation (2205)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2023 the patient had the gastrostomy balloon checked per protocol and the balloon was found without water.It was reviewed in the clinical history that the tube was placed on (b)(6) where they described that they insufflated with 5 milliliters of distilled water and it was reported to the intensivist on duty and insufflated again with 5 milliliters of water.On (b)(6) at the beginning of the shift, the surgeon enters and the situation was discussed.She reported that because it was so recent, it was better not to check the balloon again, but she did order an ultrasound of the abdomen.In the afternoon, the room was entered and the gastrostomy balloon was found on the outside.The balloon was verified and it was perforated.The intensivist and surgeon on duty who schedules for urgent surgery were informed.There was no patient injury reported.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on march 17, 2021.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.However, a supplier corrective action request has been opened to address the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR
• Type of Device: 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: 16832029
• MDR Text Key: 314180428
• Report Number: 9612030-2023-03686
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007154
• UDI-Public: 10884521007154
• Combination Product (y/n): N
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884715122
• Device Catalogue Number: 8884715122
• Device Lot Number: 2106834664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1