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

Model Number 1050044

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.When 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 after unpacking, the product leaks and there is no glue in the bottle.The event occurred prior to use with no patient involvement.

Manufacturer Narrative

Investigation: samples received: 7 open pouches.Analysis and results: there are previous complaints of the same code-batch regarding the same issue.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in b.Braun surgical's warehouse.We have received eleven open pouches that contain an unopened ampoule.All ampoules have been optically evaluated and a defect in the sealing bar of the ampoule (yellow bar at the bottom of the ampoule) was found in all units.The leakage of the glue occurs at this point.We have conducted a review of the batch manufacturing record of this product and no deviations related to this issue have been found.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.A capa has been initiated.

• Brand Name: HISTOACRYL BLUE 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: 9322602
• MDR Text Key: 172322504
• Report Number: 3003639970-2019-00748
• 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: 12/09/2019

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: 07/31/2020
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 218352N3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1