MAUDE Adverse Event Report: B. BRAUN SURGICAL SA HISTOACRYL BLUE TISSUE ADHESIVE

Model Number 1050044

Device Problem Leak/Splash (1354)

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

Event Date 12/31/2019

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.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with histoacryl.After unpacking the product, it was found that there was product leakage.There was no patient harm.

Manufacturer Narrative

No samples or picture showing the defect have been received.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.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 BLUE TISSUE ADHESIVE
• Type of Device: TISSUE ADHESIVE
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9622995
• MDR Text Key: 176122848
• Report Number: 3003639970-2020-00029
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 219135N1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1