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

Model Number 1050052

Device Problems Break (1069); Material Integrity Problem (2978)

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

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 the product is broken.The reporter indicated that the head nurse of the operating room complained that the glue was damaged during the operation.The event occurred before use on the patient.

Manufacturer Narrative

Samples received: no samples available.Analysis and results: there are previous complaints of this code batch for the same issue.We manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical warehouse.We have not received any sample.Nevertheless, ampoules received from previous complaints of the same code batch were optically evaluated and a defect in the sealing bar of the ampoule was 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 there are previous complaints confirmed of the same code batch for the same issue, we conclude that the complaint is confirmed by evidence of failure in the ampoules.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.A capa has been initiated.

• 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: 9660648
• MDR Text Key: 178036547
• Report Number: 3003639970-2020-00047
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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: 218404N2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1