MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 24FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884720247E

Device Problem Unintended Deflation (4061)

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 the balloon is deflating frequently.The balloon is asymmetrical and it deflated within 6 days.The balloon was inflated with 20 ml sterile and 20 ml sterile water as per the recommendation of the manufacturer.The experiment was started on (b)(6) after consulting a gastroenterologist.On (b)(6), the kangaroo tube deflated by 0,4 cm and continued deflating on (b)(6) by a total of 1.2 cm.Usually, gastrostomy tubes should stay till around 3-6 months.Per additional information received on 15-apr-2022, there was no patient injury or medical intervention.The experiment was done in vitro.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for the investigation, but three photos were provided.The photos were reviewed; however, the physical sample is needed for further investigation as it is not possible to confirm the reported issue or determine the root cause through an evaluation of the photos.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated to reflect our findings.Based on all available information, a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

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.One decontaminated sample was received at the manufacturing site for the investigation.Visual and functional evaluations were performed, and the reported condition could not be confirmed.The balloon was inflated with 20cc of air for 10 minutes with acceptable results according to specifications.The sample received for evaluation of the product complies with the specification according to acceptance criteria.A root cause could not be determined as the reported issue was not confirmed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Lot number which was obtained from the customer on august 02, 2022 was added to section d4.H4 updated to include manufacture date.The device history record file was reviewed, and no discrepancy was found according to the failure mode reported.

• Brand Name: GSTRO FEED TBE W/Y PRT 24FR EN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 14141233
• MDR Text Key: 289501391
• Report Number: 9612030-2022-03227
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007352
• UDI-Public: 10884521007352
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2022

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: 8884720247E
• Device Catalogue Number: 8884720247E
• Device Lot Number: 2025805164
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 03/27/2022; 03/27/2022; 03/27/2022
• Supplement Dates FDA Received: 05/07/2022; 06/28/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1