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

Model Number 1050044

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510k: k111959.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.Manufacturing site evaluation: investigation ongoing.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the histoacryl ampoule found prior to the procedure.When the pack was opened, it was noted that there had been leakage.The product was not used on a patient and there was no injury or intervention required.

Manufacturer Narrative

Samples received: 2 open samples.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) in the market.There are no units in stock in b.Braun surgical's warehouse.We have received two open samples, the ampoules received have been optically evaluated and a defect in the tip of the ampoules was found in one of them.Tip is bent.The leakage of the glue occurs at this point as can be seen in the enclosed pictures.The other unit does not show leakage signs or tip bent.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 does 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 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: 8214934
• MDR Text Key: 132537573
• Report Number: 3003639970-2019-00004
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 217394N2
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/14/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1