MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML; TISSUE ADHESIVES

Model Number 1050052

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 there were two cases of ampoule leakage in this batch number as soon as they are opened.The event occurred prior to use.

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 120 closed pouches.63 samples were tested.63 of the 120 ampoules received have been optically evaluated and a defect in the sealing bar in 7 of the units 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 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.Capa number: ak201730130.

• Brand Name: HISTOACRYL BLUE TISSUE ADHESIVE 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: 9457273
• MDR Text Key: 172609213
• Report Number: 3003639970-2019-00871
• 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

• 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: 218404N2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1