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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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 becomes available a follow up report will be submitted.

Event Description

It was reported that there was ampoule leakage.The reporter indicated that the head nurse of the operating room of the hospital stated that a large amount of glue leakage had been found during the operation recently.The event occurred prior to use.

Manufacturer Narrative

Investigation: samples received: no samples available.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and the results during the process fulfill b.Braun surgical requirements.Moreover, there are no previous complaints of this code batch.Final conclusion: without samples and/or pictures showing the defect, 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 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: 9318778
• MDR Text Key: 172261071
• Report Number: 3003639970-2019-00765
• 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: 03/18/2020

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: 218274N2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1