MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 14FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884715148

Device Problem Material Rupture (1546)

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 the balloon was ruptured.There was no patient harm.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.The device was manufactured on 29-jan-2021.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 29-jan-2021.The physical sample have been received for the evaluation.This is a component purchased is supplied by an external supplier and a complete investigation was performed by the supplier.After the decontamination of the device, a physical evaluation was conducted in review of manufacturing issues, cuts, tears, and anything abnormal that could induce reported issue.The device was then inflated with air and water to check for leaks in the balloon.The unit was filled and remained filled over an hour and no leaks or balloon deflation was observed.The balloon was filled without leaks or bursts.The reported issue could not be duplicated or confirmed, and the device functioned as intended.Additional observations were identified.When the balloon was filled, there were scuff marks on the bottom side of the balloon as if it had been hit or rubbed by an unknown object leaving a white mark.The marking was very apparent and looks like a scrape, rubbing, or intentional marking of some sort that would leave debris or permanent markings.A couple of attempts were made trying to remove the markings; however, the marking could not be removed without damaging the unit or rupturing the balloon.Therefore, the marking was left alone.Although this observation was identified, the unit still functioned as intended.No issues were observed.This observation was not a manufacturing issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 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: 15343408
• MDR Text Key: 303402865
• Report Number: 9612030-2022-03369
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521007222
• UDI-Public: 10884521007222
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

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: 8884715148
• Device Catalogue Number: 8884715148
• Device Lot Number: 2101936764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/15/2022; 08/15/2022
• Supplement Dates FDA Received: 09/23/2022; 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1