MAUDE Adverse Event Report: CONVATEC, INC. FLEXI-SEAL FMS FECAL MGMT SYSTEM KIT; TUBES, GASTROINTESTINAL, 78 KNT

Model Number 411100

Device Problem Device Inoperable (1663)

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

Event Date 09/14/2014

Event Type  malfunction  

Event Description

It is reported the product is impossible to use due to the irrigation port defect.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.Per the info received, a request was made to change the device.The device was not used on the pt due to the defect.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.There are two cases associated with this event; therefore, an add'l fda form 3500 a has been generated to address the other case.

Manufacturer Narrative

Additional information was received on 08/11/2015.Third party mfr reviewed the routers used to manufacture lot #12vm471622 and no deviations or discrepancies were noted.It was determined the lot was manufactured without incident.The retained samples for this lot were inspected and were found to be functional and non-defective.No previous investigations are available.After a thorough batch review no discrepancies or non-conformances were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 08/12/2015.

• Brand Name: FLEXI-SEAL FMS FECAL MGMT SYSTEM KIT
• Type of Device: TUBES, GASTROINTESTINAL, 78 KNT
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4206743
• MDR Text Key: 4985279
• Report Number: 1049092-2014-00559
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K032734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2017
• Device Model Number: 411100
• Device Catalogue Number: 411100
• Device Lot Number: 12VM471622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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