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

Model Number 418000

Device Problem Split (2537)

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

Event Date 10/23/2014

Event Type  malfunction  

Event Description

A user facility reported an fms balloon split prior to inserting.No medical intervention was required and ther was no harm to the patient.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.The lot number was not provided.Therefore we are unable to determine the specific manufacturing site.Both potential site numbers are listed below.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: FLEXI-SEAL SIGNAL (FMS)
• Type of Device: GASTROINTENSTINAL TUBE & ACCESSORIES
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4249876
• MDR Text Key: 16858667
• Report Number: 1049092-2014-00576
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K032734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• 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
• Date Manufacturer Received: 10/23/2014
• 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: Initial
• Patient Sequence Number: 1