MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL ® SIGNAL® FMS®; GASTROINTESTINAL TUBE & ACCESSORIES

Model Number S41800

Device Problem 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.(b)(4).

Event Description

A nurse reported that during patient use, the tubing of the flexi-seal signal device became deformed.A photo was provided of a used device showing the waste catheter which appears to justify the reported complaint.The device was replaced with another product, no patient harm was reported.

Manufacturer Narrative

Model number previously reported incorrectly.Follow up information confirmed that the deformity of the product did not cause blockage or leakage.The product was irrigated as recommended by the instructions for use (ifu) and was used for fourteen (14) days, well within the time frame indicated in the ifu.Aside from replacing the device with another device on hand, no medical intervention was required and no medications were prescribed as a result of the tubing problem.No medication was injected into the fms system prior or during the time period when the device was reported deformed.Follow up information revealed that the companion device used to replace the device associated with this mdr also malfunctioned.A separate mdr will be submitted for the second device.No additional details or patient data have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on march 17, 2016 fda registration number reporting site: 1049092 (b)(4).

• Brand Name: FLEXI-SEAL ® SIGNAL® FMS®
• Type of Device: GASTROINTESTINAL TUBE & ACCESSORIES
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5480911
• MDR Text Key: 39755797
• Report Number: 1049092-2016-00080
• 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,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

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: S41800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• 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