MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL BLUE 0.5ML

Model Number 1050044

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

Event Date 10/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological charateristics with a medical device registered within the u.S.Are.Manufacturing site evaluation: evaluation on going.

Event Description

Country of complaint: (b)(6).During the application on a wound cutting, it was noticed of a chimical reaction.It had already happened.The patients inform the operator about burning during the application.Exothermic reaction in application.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: two open units.Received two open samples with the glue polymerized at the tip and cannot be used.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Without any closed sample an analysis cannot be carried out in order to make a decision.The wound should be clean and dry, without blood present in the area.When histoacryl gets in direct contact with the blood of the wound the reaction is very fast, it cannot be discarded smoke formation in the wound area and also heat.In the precautionary measures on application in the instructions for use of the product are described these effects: "during closure of smooth and fresh skin wounds it should be ensured that the edges of the wound have been thoroughly cleaned, debrided and properly apposed before applying histoacryl.Histoacryl generates a small amount of heat during polymerization and should not be applied to tissues that may be affected by such heat.Assure haemostasis, close the dermis as needed, and assure that surface edges are easily apposable before applying histoacryl.The areas to be joined should be as dry as possible." also in the side effects paragraph: "the use of this product leads to an exothermic reaction.During the closure of smooth and fresh skin wounds the inappropriate application of too thick layer of adhesive can lead, upon polymerization, to thermal damage of the tissue." final conclusion: the complaint is not justified but the conclusion is not corresponding according to the results of the in process control when this batch was manufactured.Without samples a study cannot be conducted if the affected product does not fulfill the specifications.In consequence, a proper analysis cannot be done.Note of this case, if any sample is received in the future, the case will be re-opened and analyzed.Please note that when no samples are received our analysis is very limited.Reviewed the batch manufacturing record of this batch, the product had a normal process and no incidences were found in the production process.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: HISTOACRYL BLUE 0.5ML
• Type of Device: HISTOACRYL
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5246069
• MDR Text Key: 32008601
• Report Number: 2916714-2015-01031
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: SEENARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 215141N2
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/13/2015
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 14 YR