MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL FLEXIBLE PACK 5; TISSUE ADHESIVES

Model Number 1051250P

Device Problem Leak/Splash (1354)

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

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).When opening the package, the leakage from the ampule was already caused, therefore the product was not able to use.

Manufacturer Narrative

Samples received: 2 open pouches.Analysis and results: there is a previous complaint of this code batch regarding the same issue that was closed as confirmed after the analysis.We manufactured and distributed (b)(4) units of this code batch in the market.There are no units in stock in b.Braun surgical's warehouse.We received two open pouches.The two ampoules received have been optically evaluated and a crack at the base of the neck of the ampoule that corresponds to the injection point has been found.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: we have opened a corrective and preventive action ak201485274 in order to determine the root cause of this defect and actions.

• Brand Name: HISTOACRYL FLEXIBLE PACK 5
• Type of Device: TISSUE ADHESIVES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7476506
• MDR Text Key: 107360676
• Report Number: 3003639970-2018-00233
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K1403043
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 1051250P
• Device Catalogue Number: 1051250P
• Device Lot Number: 217211N1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2018
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other