MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH 4150

Catalog Number 4150

Device Problems Failure To Adhere Or Bond (1031); Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that when removing the dressing, the nurse found the blue scrim was separated from the foam.The patch had been placed fifty hours prior to when the issue was found, but it is not known when the separation occurred.Another product was pulled and placed on the patient's port.No adverse patient consequences reported.The product was disposed.

Manufacturer Narrative

Integra has completed their internal investigation on march 31, 2016.The investigation included: methods: review of complaints history.Results: evaluation of returned device; the sample was disposed of.The complaint could not be confirmed since no sample (or photo) was returned for evaluation.Dhr review; no lot number was reported as part of this event.Complaints history; upon review of integra's complaint system from march 2014- march 2016, a total of (b)(4) complaints (including this one) related to same issue of blue scrim delamination for biopatch product family conclusion: the complaint description states that the patch had been placed fifty hours when the delamination was noticed during product removal.There is no information regarding if there was exudation from the wound.The polyurethane disk contacting the wound acts like a sponge that absorbs exudate/moisture from the wound.With highly exudative wounds, the moisture from the exudate could soften the medical grade acrylic adhesive and make the blue nylon reinforced film (scrim) more easily to peel.In this case, detachment of the blue nylon reinforced film from the biopatch disk is possible due to the pulling force exerted during the removal of the transparent film dressing that secures the device and biopatch disk to the skin.Since detachment of the blue nylon reinforced film (scrim) is most likely to occur during removal of the biopatch disk, which is then discarded, it has no impact on patient care.

• Brand Name: BIOPATCH 4150
• Type of Device: BIOPATCH
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5508953
• MDR Text Key: 40844061
• Report Number: 2648988-2016-00012
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K003229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4150
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• 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