MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX; ACCESSORIES, CATHETER

Catalog Number 409511CN

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).No sample has been returned for investigation.We received one photo of a discofix-3 blue.The photo shows a leakage.However, it cannot be determined from where the leakage has originated or what the root cause of the leakage is.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.The manufacturing documentation and machine papers have been checked.There are no deviation or entries noted which could lead to a failure as complained.Besides, 5 pcs retained samples have been visual checked as well.There are no abnormalities observed.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): serious adverse event.Discofix 3-way stopcock was used for infusion and pressure monitoring of icu patient.8 hours later it was found that the discofix was broken and liquid leaked.Vasoactive drug was not infused properly.Ventilator alarm showed patient's blood pressure decreased.The discofix was replaced immediately.After detection of the leakage, emergency treatment was given and the patient has recovered.Due to covid-19 pandemic, no sample available.

• Brand Name: DISCOFIX
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 9898420
• MDR Text Key: 187874920
• Report Number: 9610825-2020-00072
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: 409511CN
• Device Lot Number: 18L2892041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention