MAUDE Adverse Event Report: CONVATEC INC. FLEXI SEAL SIGNAL (FMS); GASTROINTESTINAL TUBE & ACCESSORIES

Model Number S418000

Device Problems Material Too Rigid or Stiff (1544); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed and will be monitored through our post market product monitoring review process.Follow-up details have been requested but have not been received to date.Should additional information become available, a follow-up report will be submitted.Note: two cases associated with this complaint.A separate 3500a form has been completed for the other case.(b)(4).

Event Description

A nurse reported that during patient use, a second fms device was inserted for management of profuse, loose stool in a patient who was admitted to itu after presenting with low glasgow coma scale (gcs) and hyperpyrexia following "taking a legal high." the reporter stated that the fms device malfunctioned in the same manner as the first fms device - with the waste "tubing becoming deformed and rigid." the second fms device was discontinued because the patient no longer required it.Reporter stated no leakage or blockage was noted and no patient harm occurred.The total length of time of fms was use in the patient was 20 days.A photo was provided of a used device showing the waste catheter which appears to justify the reported complaint.

• Brand Name: FLEXI SEAL SIGNAL (FMS)
• Type of Device: GASTROINTESTINAL TUBE & 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: 5527296
• MDR Text Key: 41214975
• Report Number: 1049092-2016-00119
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2016

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: S418000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/25/2016
• 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