MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH 4150

Catalog Number 4150

Device Problems Sticking (1597); Delamination (2904)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Event Description

Total of 3 complaints opened for this event to capture the issue/lot numbers.This is report 3 of 3.It was reported by the sales rep.That during dressing changes, the blue top is delaminating from the foam and wrapping around the catheter.This is reported to be happening "every time", but no specific number of occurrences has been recorded.He also states there is a difference in the feeling of the device.No patient consequences were reported.No product has been saved.

Manufacturer Narrative

This is the 3rd of 3 reports from the same customer, same product problem, different product id/lot numbers: 2648988-2015-00058; 2648988-2015-00059; 2648988-2015-00060.Additional information received: catheter dislodgement is a concern.When the product delaminates, the blue scrim is wrapping around the catheter, which may lead to a potential dislodgement.Also, the customer normally experiences delamination when the product is saturated; however, they now experience delamination even when the product is dry.Dressing change protocol is for 7 day dressing change, but dressings are changed prn if needed.The skin prep is allowed to dry prior to the product application, per protocol.The 3m transparent film dressing is the cover dressing used over the product.Integra has completed their internal investigation on 5aug2015.The additional investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: device history record (dhr) of the finish good (fg) lot # 1151003 and 1151189 were reviewed in order to detect any anomalies that could have occurred during the manufacturing process of the product which could have contributed and/or be related with the reported condition being investigated (blue top delamination).Fg lot # 1151003 and 1151189 were manufactured in 2015-03 and the expiration date is 2017-03.As part of the manufacturing process, controls are in place to detect delamination of the scrim from the foam.A 100% visual inspection for proper adhesion between the scrim and foam is performed by manufacturing personnel as per applicable procedure and by quality control.(b)(4).Conclusion: (b)(4).In addition, the adhesive used on the film material is dispersible in water.Consequently, an oversaturated dressing has the potential to cause detachment of the scrim material from the chg drug loaded polyurethane foam.This oversaturation condition is not related to a malfunction of the biopatch disk and does not affect the drug release effect of the product.

• Brand Name: BIOPATCH 4150
• Type of Device: BIOPATCH
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 8006542873
• MDR Report Key: 4938359
• MDR Text Key: 22711019
• Report Number: 2648988-2015-00060
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 4150
• Device Lot Number: 1151189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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