MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 418000

Device Problem Split (2537)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

It was reported the medical port split when the staff nurse was attempting to give the end user an enema.She was using a 50cc syringe at the time.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It was further stated that there were no bodily injuries reported due to the device malfunction and the device was thrown away.Additional information was requested, however no additional patient/event details have been provided to date.No sample is expected to be returned.Should additional information become available, a follow-up report will be submitted.The lot number was not provided.

• Brand Name: FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, in. ass. dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4188301
• MDR Text Key: 5160649
• Report Number: 1049092-2014-00529
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention