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

Model Number 1050044

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

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 leakage occurred.The reporter indicated that after unpacking, the product leaks and there is no glue in the bottle.No patient involvement.

Manufacturer Narrative

Investigation: samples received: 1 open pouch.Analysis and results: there is a previous complaint of this code batch, regarding the same issue received from the same hospital.We manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received an open pouch.The ampoule has been visually checked and the tip slightly bent, then is it possible that 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 sample received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the sample received.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.No corrective/preventive actions needed.

• 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: 9150879
• MDR Text Key: 172019288
• Report Number: 3003639970-2019-00658
• 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: 12/06/2019

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: 217492N1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1