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

Model Number 1050044

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: none analysis and results: batch manufacturing review could not be done as we have not received the list of possible batches.However, taking into account the complaint description we can consider that the product has not been applied according to the instructions for use of the product: mode of action for closure of smooth and fresh skin wounds in the presence of tissue moisture histoacryl immediately polymerizes into a solid substance which attached firmly to the tissue.Warning note during closure of smooth and fresh skin wounds histoacryl must not be introduced into the wound, since this would interfere with wound healing.Precautionary measures on application 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.Local anesthesia might be necessary.(.) 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.The skin surfaces should be held together for 30 seconds after application of histoacryl.Final conclusion:without any closed samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incident and if any samples are received in the future, the case will be re-opened and analyzed.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).It was reported that the glue crystalises upon contact with blood.

• Brand Name: HISTOACRYL BLUE 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: 7534401
• MDR Text Key: 108985294
• Report Number: 3003639970-2018-00281
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 01/30/2018
• 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