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

Catalog Number 409511CN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

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.

Event Description

As reported by the user facility / translation of user facility information by bbm sales organization in china: "leakage".According to the customer: "description of malfunction / failure: consumables quality issues.Description of event: since on (b)(6) 2022, our icu has fed back that braun has always had the problem of liquid leakage during the use of this batch of tee, and when connecting, one liquid leakage leakage is used.On (b)(6) 2023, when the medical staff used the tee, the blood jumped out from the three-way connection and suspected the three-way dehiscence, which caused serious adverse effects on the patients.The head nurse fed back that there were 20-30 problems of blood leakage and blood leakage, which had great hidden dangers for the safety of the patients.Description of root cause analysis (by reporter):consumables quality issues.Preliminary handling of event:the head nurse reported the leakage video, picture and report of this event and the tee to the medical staff, contacted the consumable purchaser, contacted the manufacturer, contacted the manufacturer for procurement, and returned and exchanged the tee.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).No sample and no picture has been provided for investigation.Errors of cracking and leakage are not unknown within the standard discofix portfolio.The material is known to be susceptible to fissure formation.An explicit warning note is included in the ifu for the device.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: 17352323
• MDR Text Key: 319419280
• Report Number: 9610825-2023-00065
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: 21M06D9046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2023
• 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
• Patient Outcome(s): Death