MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML; TISSUE ADHESIVES

Model Number 1050052

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 5 unopened pouches.Analysis and results: there are no previous complaints of the same code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Reviewed the batch manufacturing record, this product had a normal process and no incidences were found in the production process.Remarks: before applying histoacryl, 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 hemostasis, 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: after investigation, it is concluded that there are no manufacturing fault or material defect that could have caused this issue.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).In surgery, a patient entered in order to be laparoscopically.At the end of the wound closure procedure, as the clinic used, skin glue was used.When applied to the edges of the wound, smoke appeared, probably due to a chemical reaction, while the surgeon who used the glue felt a feeling of burning.

• Brand Name: HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7597057
• MDR Text Key: 111021335
• Report Number: 3003639970-2018-00351
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 217473N1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Distributor Facility Aware Date: 05/30/2018
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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