MAUDE Adverse Event Report: B. BRAUN SURGICAL SA HISTOACRYL FLEXIBLE PACK 5; TISSUE ADHESIVES

Model Number 1051250P

Device Problem Leak/Splash (1354)

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

Event Date 01/21/2020

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.K140343.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with the histoacryl flexible pack.The customer reported leakage was confirmed before opening the package.There is no patient information provided as the event occurred before use.

Manufacturer Narrative

Complaint description: leakage was confirmed before opening the package.Patient information: not applicable, before use.Samples received: 1 open pouches, unopened ampoule.Analysis and results: there are no 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 one open pouch (closed ampoule) showing ampoule leakage.The ampoule received has been optically evaluated and a defect in the sealing bar of the ampoule was found.The leakage of the glue occurs at this point.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: 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 FLEXIBLE PACK 5
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9693471
• MDR Text Key: 178563057
• Report Number: 3003639970-2020-00066
• 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: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 1051250P
• Device Catalogue Number: 1051250P
• Device Lot Number: 219045N1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1