MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Model Number 456020

Device Problem Leak/Splash (1354)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

As reported by the user facility: description: stopcock (despite being tightened) leaking propofol infusion all over patient; and patient not getting proper dose leading patient to wake up and potentially harm self or self-extubate when goal was to keep them sedated.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.The returned sample was visually inspected as per specification with failing results.It is noted the discofix d500 4-way spin lock is snapped off the adaptor.Although the returned sample was damaged the defect could not be confirmed for a broken stopcock to be a result of any manufacturing/packaging process.While an exact root cause cannot be determined, a review of the complaint sample suggests that the breakage did not originate from a failure in the manufacturing process.Based on these findings the most likely potential cause is that the defect originated from the excessive force being placed on the valve during use.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DISCOFIX®
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14675539
• MDR Text Key: 296973005
• Report Number: 2523676-2022-00258
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: (01)04046964996962
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 456020
• Device Catalogue Number: 456020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• 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