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 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: k111959.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.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with histocryl.On (b)(6) 2019, the doctor was preparing to use glue for skin tissue bonding, but after unpacking the product, he found that all the glue in the product leaked out.The malfunction occurred prior to use.

Manufacturer Narrative

Investigation: samples received: 1 unopened pouch.Analysis and results: there are previous complaints of this code batch 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 1 unopened pouch.The ampoule received has been optically evaluated and a defect in the sealing bar in the ampoule was found.The leakage of the glue occurs at this point as can be seen in the enclosed picture.Reviewed the batch manufacturing record, this product had an incidence not related to this issue 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.A corrective/preventive action has been initiated.

• 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: 9603319
• MDR Text Key: 175452459
• Report Number: 3003639970-2020-00009
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 218404N1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1