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 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 15-apr-2022, 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.

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.

Manufacturer Narrative

A device history record (dhr) review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all dhrs are reviewed and approved by quality, prior to the release of product.One decontaminated sample was received at the manufacturing site for the investigation.A visual inspection was performed.A burst balloon was observed.The y-port was not returned for evaluation.This affected component is purchased from an external supplier.A complaint notification was sent to the supplier along with pictures and videos to initiate an investigation.Per the supplier, the reported condition of a burst balloon was confirmed.Discoloration and encrustation of the balloon were also observed.A definitive root cause could not be determined based on all available information, but it is possible that unique patient factors such as diagnosis, treatment, surgical procedures, medications, nutrition formulas, and gastric ph could affect the balloon¿s life.Some patients may also ingest food orally when the device is still in place which could also impact the balloons performance.Controls that are in place include training and certification on all manufacturing operations and quality control inspectors as well as proper training on equipment used in the process.There are defined dimensional visual and physical requirements, testing methods, and dhrs/pictorial instructions provided at each workstation in the production line.Work instructions that provide guidance for material verification, line clearance, and quality control inspection sampling are followed.The manufacturing suite is maintained to the highest standards with rules outlining cleanroom operation parameters (i.E., temperature and humidity controls) and cleaning schedules for the cleanroom, lim equipment, and milling machines.Additionally, there are procedures outlining general personnel requirements for cleanroom usage.To mitigate the risk of releasing devices with defects, each unit is 100% inflation tested during the process.Based on all available information a corrective action is not applicable at this time.However, the supplier will continue to monitor any trends that require immediate attention.This complaint will be used for tracking and trending purposes.

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.

• 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: 14141219
• MDR Text Key: 289502038
• Report Number: 9612030-2022-03224
• 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

• Date FDA Received: 04/19/2022
• 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
• Date Manufacturer Received: 03/27/2022
• 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