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

Model Number 1050060

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 that the histoacryl was leaking.The reporter indicated that after opening the package it was found the glue (histoacryl) had leaked and hardened before using.

Manufacturer Narrative

Investigation: samples received: none.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have not received any sample for analysis.Without any sample we cannot carry out an analysis in order to take a decision.We have conducted a review of the device history record of this product and no deviations have been found.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.Actions on product distributed 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 TISSUE ADHES.TRNS 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: 9008572
• MDR Text Key: 159357214
• Report Number: 3003639970-2019-00634
• 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: 12/16/2019

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 Expiration Date: 09/30/2020
• Device Model Number: 1050060
• Device Catalogue Number: 1050060
• Device Lot Number: 218442N2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1