MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH, UNKNOWN SIZE/PRODUCT ID; ANTIMICROBIAL PRODUCTS

Catalog Number XXX-BIOPATCH

Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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

Asaio journal (2016) published, "retrospective observational review of percutaneous cannulation for extracorporeal membrane oxygenation".The purpose of this article is to describe the approach to cannulation and its complications for patients with severe respiratory failure.It were identified 348 cannulae placed in 179 patients commenced on venovenous extracorporeal membrane oxygenation from december 2011 to march 2015.All cannulas were secured using multiple 1-0 silk ties (minimum 3points) and dressed with chlorhexidine sponge discs (biopatch; ethicon) and occlusive dressings.Cannula site infections occurred in 1.4% (5/348), all of which were managed successfully with intravenous antibiotics.The site infections were not associated with signs of systemic sepsis.There were no bloodstream infections secondary to cannula infection on cultures drawn from circuits where cannula infections were clinically apparent.

Manufacturer Narrative

Integra has completed their internal investigation on january 19, 2018.Results: the units involved in the reported incidents were used during a medical study performed from 2011 to 2015 years and are not available to perform a failure analysis.Therefore, the reported condition of infection and/or dermatitis is unconfirmed.Dhr review; no device history record (dhr) was possible since no lot number was identified by the customer.Complaints history; the complaint information indicates that patients suffered ¿cannula site infection¿ during the study.Upon review of integra's complaint system from december 2015 ¿ january 16, 2018, a total of nine (9) complaints (including this one) related to infection for biopatch product family.(b)(4).Conclusion: potential root cause for ¿cannula site infection¿ cannot be determined, because it is unknown the environmental conditions where the patients were exposed during the study and, moreover, the patients¿ conditions prior to the biopatch application.Part of the recommendations for the use of the product is that the ¿biopatch should not be placed over infected wounds.¿ in addition, biopatch¿s ifu literature recognizes the possibility of adverse reactions: ¿adverse reactions to chlorhexidine gluconate such as dermatitis, hypersensitivity, and generalized allergic reactions are very rare, but if any such reactions occur, discontinue use of the dressing immediately.¿.

• Brand Name: BIOPATCH, UNKNOWN SIZE/PRODUCT ID
• Type of Device: ANTIMICROBIAL PRODUCTS
• 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: 7142524
• MDR Text Key: 95723734
• Report Number: 2648988-2017-00059
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BIOPATCH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2018
• 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
• Patient Outcome(s): Other