MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE MEPORE FILM; DRESSING, WOUND HYDROPHILIC

Catalog Number 271500

Device Problem Sticking (1597)

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

Event Date 12/01/2014

Event Type  Injury  

Event Description

(b)(4).Received notification on 2/24/2015 regarding an incident that occurred in (b)(6) 2014 in (b)(6).This incident was reported to sales rep at that time as part of market feedback and was not initially issued as a complaint in the vigilance system.Incident formally logged as complaint on (b)(6) 2015.Complaint description: customer concerned that mepore film tackiness on picc patients is causing picc line to migrate.Peripherally inserted central catheters that have inadvertently migrated can lead to adverse outcomes both in financial terms and in relation to the clinical management and outcomes for patients, such as delayed therapy, and clinical morbidities such as thrombosis.The tackiness issue is apparent across most picc patients, not an individual occurrence - many nurses complaining about this.Mepore film becomes tacky on young oily type skin.Then the film tacks to the top surface of the biopatch, adhering strongly to the patch and skin.Dressings are changed every 7 days as per protocol, and due to the tackiness this is often causing the picc line to migrate.Prior to dressing application, skin is cleansed with chlorhexidine 2% and alcohol 70% and allowed to dry.Picc lines are not sutured or glues in.Wellington hospital use two types of patches and are guided to use biopatch unless sensitive to chg where they will then turn to silversorb.Biopatch (chlorhexidine) has a foam surface to the skin and plastic surface to the dressing.Silver patch (used when sensitive to chlorhexidine) silversorb this is a rubber type substance which has a low profile.The main concern is the tackiness of the mepore film dressing on the disc and the skin.The issue is widespread so could be several batches.

Manufacturer Narrative

We are currently waiting on the sample to be returned in order to complete a thorough investigation.We will send follow up with investigation details and conclusion.

• Brand Name: MEPORE FILM
• Type of Device: DRESSING, WOUND HYDROPHILIC
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; norcross GA
• Manufacturer Contact: jamie bradshaw ; 5550 peachtree parkway; suite 500; norcross, GA 30092 ; 4703750051
• MDR Report Key: 4608472
• MDR Text Key: 19501108
• Report Number: 3004763499-2015-00001
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 271500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other