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

Model Number 1050052

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Leakage was found after opened the package.

Manufacturer Narrative

Samples received: 5 unopened and 2 opened pouches received: analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 4,210 units.There are no units in stock in b.Braun surgical's warehouse.We have received 5 unopened and 2 open pouches with an ampoule.The five closed samples have been opened and optically evaluated and the ampoules inside do not present leakage.The other two ampoules received from an open pouch have also been optically evaluated and a defect in the tip of the ampoule has been 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 samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the samples received.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: 7454148
• MDR Text Key: 106442842
• Report Number: 3003639970-2018-00232
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: 217381N2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2018
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other