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

Model Number 1050052

Device Problem Fluid/Blood Leak (1250)

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 ampoule leakage occurred.The reporter indicated that the glue was leaking before the package was opened.The event occurred before use with no patient harm.

Manufacturer Narrative

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's warehouse.We have received 5 unopened ampoules.All ampoules have been visually evaluated and two defective areas are found.The leakage occurs at the bottom part of the ampoule but also there are flow lines in the ampoule in the area between the cannula and the body of the ampoule.These two defects appear when histoacryl is stored or has been under higher temperatures than 22ºc.In this case, we assume that at some point, outside b.Braun surgical's warehouse, the samples were stored or suffered from temperatures higher than 22ºc and the leakage appeared because of this reason.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: although the results of the samples received do not fulfil b.Braun surgical specifications and that the complaint is considered confirmed, we assume that the storage at higher temperature than the indicated in the product box was outside b.Braun surgical's warehouse.We take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Actions on product distributed 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, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• 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: 9555646
• MDR Text Key: 173938760
• Report Number: 3003639970-2019-00963
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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: 218342N3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1