MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 20FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720205
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that within 6hrs, the bulb deflated on its own.They just inserted one as well with no issues to date from the same order.Per additional information received, the patient developed peritonitis to the abdomen after the gastric acids and stomach contents ended up in the abdomen causing an infection (fever and redness to abd).His level of consciousness decreased and he stopped eating for a few days.This eventually improved as he was given a trial period of antibiotics.The status of the patient is post stroke, acp c (pre this event).
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.Upon functional evaluation of the sample, the reported issue was not confirmed; the balloon was inflated and immersed in water without any leakage.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.

• Brand Name: GSTRO FEED TBE W/Y PRT 20FR
• Common Device Name: 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: 19454219
• Report Number: 9612030-2024-00077
• Device Sequence Number: 15226318
• Product Code: KNT
• UDI-Device Identifier: 10884521007291
• UDI-Public: 10884521007291
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720205
• Device Catalogue Number: 8884720205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown