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 Consequences Or Impact To Patient (2199)

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 when the package was opened it was found that the glue inside was leaking and the bottle was empty, so it could not be used.The event was found prior to use on the patient.

Manufacturer Narrative

Analysis and results: there are previous complaints of this code batch for the same issue.We manufactured and distributed in the market (b)(4) units.There are (b)(4) units blocked in stock in b.Braun surgical warehouse.We have not received any sample.Nevertheless, ampoules received from previous complaints of the same code batch were 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 an incidence not related to this issue and was released fulfilling b.Braun surgical specifications.Final conclusion: taking into account that there are previous complaints confirmed of the same code batch for the same issue, we conclude that the complaint is confirmed by evidence of failure in the ampoules.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: 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: 9383019
• MDR Text Key: 172460768
• Report Number: 3003639970-2019-00826
• 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: 02/20/2020

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 Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 218352N3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1