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

Model Number 1050044

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

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.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there was ampoule leakage.The reporter indicated that the hospital opened the glue package and found leakage.The hospital requires to replace all the remaining glue in this batch number, a total of 580 pieces.The event occurred during a procedure with no patient harm.

Manufacturer Narrative

Investigation: samples received: (b)(4) unopened and (b)(4) 5 open pouches.Analysis and results: there are previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical warehouse.We have received (b)(4) closed pouches and 5 open pouches (closed ampoules) showing ampoule leakage.Some of the ampoules received have been optically evaluated and a defect in the sealing bar of the ampoule was found.(b)(4) units have been tested and 6 were defective.The leakage of the glue occurs at this point as can be seen in the enclosed picture.Reviewed the batch manufacturing record, this product had an incidence not related to this issue and was released fulfilling b.Braun surgical specifications.Final conclusion: taking into account that the results of the samples received do not fulfil b.Braun surgical specifications, and that there are several previous complaints for the same defect, we conclude that the complaint is confirmed by evidence of failure in 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.A capa has been initiated.

• 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: 9452572
• MDR Text Key: 172608303
• Report Number: 3003639970-2019-00870
• 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: 01/17/2020

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 Expiration Date: 08/31/2020
• Device Model Number: 1050044
• Device Catalogue Number: 1050044
• Device Lot Number: 218381N2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1