MAUDE Adverse Event Report: B. RAUN SURGICAL S.A. HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML; ADHESIVES

Model Number 1050052

Device Problem Chemical Problem (2893)

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

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Glue is too hard, feels like wax and glue does not stick.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 3 unopened units.Analysis and results: there are no previous complaints of this code batch.(b)(4) units of this product were manufactured and distributed, there are no units in stock.Tested the wound closure strength of the samples received and have not found any significant differences.The result is correct.This test method is a standard test method for determining the comparative wound closure strength of tissue adhesives and covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue.Tested the adhesive strength of the samples received and the result fulfills the oem product specification.The viscosity has been tested and the result is slightly higher, but it is into the current range for this product.Nevertheless, the result is based in only one value as the sample quantity was very low.The polymerization time, histoacryl of the samples received polymerized as expected, no differences have been found with the standard values.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil product specifications.Final conclusion: complaint is not justified.Actions on product: not applicable.Corrective/preventive actions: not applicable.

• Brand Name: HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML
• Type of Device: ADHESIVES
• Manufacturer (Section D): B. RAUN SURGICAL S.A.; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAU SURGICAL S.A.; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5032883
• MDR Text Key: 24253861
• Report Number: 2916714-2015-00753
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 214511N2
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• 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