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

Model Number	8884720247E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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.
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.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.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2022-03227
• Device Sequence Number: 11768578
• Product Code: KNT
• UDI-Device Identifier: 10884521007352
• UDI-Public: 10884521007352
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2022
• Supplement Date Received by Manufacturer: 03/27/2022; 03/27/2022; 03/27/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/07/2022; 06/28/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown