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

Model Number 1050052

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information and investigation results will be provided, if applicable.

Event Description

It was reported that there was an issue with histocryl.Late (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.It was noted that this was found in 3 products.The malfunction occurred prior to use.

Manufacturer Narrative

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 3 open pouches (unopened ampoules).The ampoules received have been optically evaluated and a defect in the sealing bar in the ampoules received was found.The leakage of the glue occurs at this point.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 samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the samples 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.

• Brand Name: HISTOACRYL BLUE TISSUE ADHESIVE
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9602979
• MDR Text Key: 175452491
• Report Number: 3003639970-2020-00007
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K111959
• 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: 02/04/2020

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 Model Number: 1050052
• Device Catalogue Number: 1050052
• Device Lot Number: 218404N1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1