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

Model Number 1050052

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

Analysis and results: there are previous complaints of this code batch regarding the same issue of which we manufactured and distributed in the market (b)(4).There are no units in stock in b.Braun surgical warehouse.We have received one open pouch with a closed ampoule.The ampoule received has been optically evaluated and a defect in the sealing bar was found.The leakage of the glue occurs at this point.Reviewed the batch manufacturing record, this product had a normal process and 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.Corrective/preventive actions: according to our internal procedures, we have opened a capa in the system in order to determine root cause and actions to correct/prevent this defect to happen.Capa number: ak201730130.

• 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: 9622885
• MDR Text Key: 176123205
• Report Number: 3003639970-2020-00030
• 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: 02/13/2020

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 Expiration Date: 09/30/2020
• Device Model Number: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 218404N2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1