MAUDE Adverse Event Report: CONVATEC LIMITED EPI-FIX FIXATION DEVICE; TAPE AND BANDAGE, ADHESIVE

Model Number 417111

Device Problem Defective Device (2588)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported the fixation device's beige adhesive separated from the inspection window, leaving the epidural catheter with no protection at the insertion point.The catheter was fixated with another fixation device/dressing to protect the inserting point.The patient was monitored and no signs of infection were noted after 24 hours.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.Although this event was reported by a representative from (b)(6) hospital, the event allegedly occurred at (b)(6) hospital, (b)(6).

• Brand Name: EPI-FIX FIXATION DEVICE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4752127
• MDR Text Key: 19357425
• Report Number: 1000317571-2015-00043
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 417111
• Device Lot Number: 4A01502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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