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

Model Number 1050044

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 08/21/2019

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 other technological characteristics are registered within the u.S.K111959.If additional information is received a follow up report will be submitted.

Event Description

It was reported the histoacryl was leaking.The reporter indicated that when opening the package it was found the leakage from the ampule had already occurred, therefore the product could not be used.Additional information was not provided.

Manufacturer Narrative

Investigation: samples received: 1 open pouch.Analysis and results: there are previous complaints of the same code-batch regarding the same issue.We manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical warehouse.We have received one open pouch that contains one unopened ampoule.The ampoule of the open sample received has been optically evaluated and a defect in the sealing bar of the ampoule (yellow bar at the bottom of the ampoule) was found.The leakage of the glue occurs at this point.Reviewed the batch manufacturing record of this product, there are no incidences related to this issue, and the product was released fulfilling b.Braun surgical specifications.Final conclusion: taking into account that the results of the sample received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the sample received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

• 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
• MDR Report Key: 9039623
• MDR Text Key: 158636313
• Report Number: 3003639970-2019-00637
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 218353N3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1