MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
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 bubble/bulb burst when filled with sterile water.The nurse used a 10ml syringe to fill it with 15ml of water so it wasn't overfilled.There was no patient injury.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed, and no discrepancy was found according to the failure mode reported.The device was manufactured on june 10, 2021.One sample with an unknown lot number was received at the manufacturing site for investigation.A visual inspection was performed, and the reported condition was confirmed; a burst balloon was observed.This is a component purchased from an external supplier.A complaint notification was sent to the provider along with the sample to initiate the investigation.Per the supplier, the sample was evaluated, and the reported condition was confirmed.This incident is not considered an out of box failure as the device was used, obvious wear and usage were present.In further review of the balloon under a microscope and visual inspection, the balloon burst was 90 degrees to the left of the balloon inflation notch.Water was used to verify there were no obstructions and that there was a clear passageway for water and/or air flow.Due to the burst, the balloon could not be inflated.In review of any other abnormalities such as, voids, knicks, manufacturing defects, etc., there are no visual defects that definitively confirm the root cause.Because this device was used in the patient for an unknown amount of time, it is subject to mishandling, manipulation, patient conditions, and/or degradation over time of use.Therefore, the root cause cannot be confirmed.Additional possibilities that affect balloon life include unique patient factors such as diagnosis, treatment, surgical procedures, as well as medications, nutrition formulas, and gastric ph.Some patients also ingest food orally when the device is still in place which could also impact the balloon performance of the device.Current controls in place include training and certification on all manufacturing operations and qc inspectors as well as proper training on equipment used in the process.There are defined dimensional, visual, and physical requirements, testing methods and dhr/pics (pictorial instruction) provided at each workstation in the production line.Work instructions provide guidance for material verification, line clearance, and qc 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.The supplier will continue to monitor any trends to determine the need for corrective action.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048 ; MX 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: 14854393
• Report Number: 9612030-2022-03300
• Device Sequence Number: 11989326
• Product Code: KNT
• UDI-Device Identifier: 10884521007321
• UDI-Public: 10884521007321
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 2115942464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown