MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX®; STOPCOCK

Catalog Number 409511CN

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.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 china: "broken.".Description of malfunction/failure: "three-way rupture.".Description of event: " on (b)(6) 2023, the patient had low blood pressure, and norepinephrine was pumped according to the doctor 's advice to maintain blood pressure at about 120/68 mmhg, 15; 43 samples, the patient' s blood pressure decreased and heart rate accelerated.The patient and the right clavicular vein access were immediately examined, and it was found that the three-way switch pumped into the norepinephrine access ruptured, resulting in blood return from the venous access.The norepinephrine drug was not pumped into the body, resulting in a decrease in the patient 's blood pressure, causing hemodynamic instability and crisis of the patient' s vital signs.The three-way switch was replaced immediately after discovery, and the norepinephrine pump speed was increased.After the patient 's blood pressure increased to normal, the vasoactive drug pump speed was gradually reduced.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The manufacturing documentation and machine papers have been checked.There are no deviation or entries noted, which could lead to the failure as complained.We have no indication of a problem during the manufacturing process.Besides, (b)(4) pcs retained samples were visually inspected for the defect characteristic damage/crack.All inspected samples show no irregularities.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.

• Brand Name: DISCOFIX®
• Type of Device: STOPCOCK
• 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 18109 ; 4847197287
• MDR Report Key: 17224546
• MDR Text Key: 318084588
• Report Number: 9610825-2023-00289
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 409511CN
• Device Lot Number: 22E15D9041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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