MAUDE Adverse Event Report: CONVATEC INC. FLEXI SEAL SIGNAL (FMS) SYSTEM WITH ZEOLITE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 418000

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Based on available information no patient harm occurred.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but have not been received to date.When additional information becomes available, a follow-up report will be submitted.

Event Description

It was reported that the waste catheter of the device had changed appearance.The reporter stated that "the patient lay on a warm mattress and the staff thinks it might be something with the feces of the patient that makes this." photos were provided which showed puckering and deformation of the waste catheter.However, no patient harm was reported.No further information was provided.

• Brand Name: FLEXI SEAL SIGNAL (FMS) SYSTEM WITH ZEOLITE
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5763381
• MDR Text Key: 48627330
• Report Number: 1049092-2016-00298
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K150350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2016

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 Operator: Health Professional
• Device Model Number: 418000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1