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	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have had incidents of breach in patient safety in less than 2 weeks because of a balloon detachment using this product.They didn't have any problem with the old brand of the kangaroo products but according to their evaluation of this new one, it had a defect since they tried inflating the balloon to monitor it for 24 hours and after 3 hours, they found that the balloon deflated by 50%.The nurses complained that the y-port (upper part where the feeding tube is attached) was getting loose after using it for some time.Per additional information received on 03apr2022, the customer stated that the balloon burst.Per additional information received on 15apr2022, an indwelling catheter was inserted as a replacement in some of the patients.In two of the patients, the stoma was still immature due the dislodgement of the device.There was no patient injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
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.There were no physical samples or digital images received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.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.We will continue to monitor the process, complaints, and feedback for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Lot number which was obtained from the customer on (b)(6) 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.
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 and a tension test between the connector and the y-port with a minimum of 31 lbs was completed with acceptable results.The sample received for evaluation of the product complies with the specification according 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.

• 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: 14141225
• Report Number: 9612030-2022-03226
• Device Sequence Number: 17216829
• 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): Follow-Up
• 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: 04/20/2022; 06/24/2022; 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