MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	421630
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rn attempted to flush water through rectal tube in preparation for medication administration when noticed buldging of the rectal tube in various spots with concern for outpouching of fluid and potential rupture.Rectal tube removed and new rectal tube placed.No known injury at this time.

• Brand Name: FLEXI-SEAL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC, INC.; 7815 national service road; suite 600; greensboro NC 27409
• MDR Report Key: 24245993
• Report Number: 24245993
• Device Sequence Number: 12848523
• Product Code: KNT
• UDI-Device Identifier: 00768455143016
• UDI-Public: (01)00768455143016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

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: 421630
• Device Catalogue Number: REF 421630
• Device Lot Number: 25FM0525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/21/2026