MAUDE Adverse Event Report: CONVATEC, INC FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT; GASTROINTESTINAL TUBE & ACCESSORIES, 78 KNT

Model Number 418000

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

The icu nurse reported that she rolled the pt over to check the device placement, reached up to grab the tubing and the device fell out of rectum with balloon deflated.Upon inspection, she determined the balloon was in one piece but split in half in one spot.She stated it had been reported to her from a previous shift that stool had been leaking around device.She left the device out.The nurse was unsure when the device had been placed, however she stated after (b)(6) 2014.The indication for use was liquid stools.The nurse reported the packaging with lot number was thrown away.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.A return sample for eval is not expected.The lot number was not provided.Therefore, we are unable to determine the specific manufacturing site.Reported to the fda on (b)(4) 2014.

• Brand Name: FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT
• Type of Device: GASTROINTESTINAL TUBE & ACCESSORIES, 78 KNT
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4058812
• MDR Text Key: 4904157
• Report Number: 1049092-2014-00413
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• 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
• Patient Age: 80 YR
• Patient Weight: 90