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

Model Number N/A

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/06/2022

Event Type  Injury  

Event Description

As reported by the user facility / translation of user facility information by bbm sales organization in france: "stopcock-damaged-broken." according to the customer: "during monitoring by nurse.Patient found with significant bleeding.The ide identifies the cause, the valve connected to the central venous line is broken at the level of the connector.".

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.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).We received two used discofix-3 blau 2ver ms without packaging.The received samples were taken to a visual inspection according to test method damages.We detected that the la-cone of the used discofix-3 blau 2ver ms is broken off and attached to a component from a competitor.Please note: difficulties while separate the lock-connection might occur, if the components were pre-moistened with infusion solution followed by a high tightening torque.Therefore we assume of a problem during the application process, a high lateral force has acted on the connection.Based on the conducted investigation the received samples are within the specification.Therefore the complaint is considered as not confirmed.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: 15542605
• MDR Text Key: 301169986
• Report Number: 9610825-2022-00397
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4095111
• Device Lot Number: 21F29D9045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death