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

Model Number 1050060

Device Problems Partial Blockage (1065); Leak/Splash (1354)

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that there were two different cases for the same batch 216254n2: the complaint histoacryl leaked to outside and it became polymerized.The tip of the ampoule was blocked.

Manufacturer Narrative

Samples received: none.Analysis and results: there are no previous complaints of this batch of which (b)(4) units were manufactured and distributed in the market.There are no units in b.Braun surgical, (b)(4) stock.As no samples have been received and no units are available in b.Braun surgical, (b)(4).We have only reviewed the batch manufacturing record and this product had a normal process and the results during the process fulfill b.Braun surgical requirements.Final conclusion: without samples we are not in position of studying if the affected product does not fulfill the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.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 TISSUE ADHES.TRNS 0.5ML
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6531069
• MDR Text Key: 74092050
• Report Number: 3003639970-2017-00207
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: NARRATIVE
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1050060
• Device Catalogue Number: 1050060
• Device Lot Number: 216254N2
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/06/2017
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other