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 01/24/2022

Event Type  malfunction  

Event Description

As reported by the user facility: event 1: details of complaint (reported issue): stopcock on a few occasions has been cracked and leaking."pt had fentanyl, propofol & norepinephrine infusing into a cvc lumen and running through 2 stopcocks.Pt was noted to be more "awake" and infusions were increased.Then noticed pool of liquid at the head of bed, tracing back to the stopcock connection site was cracked".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample was provided for further evaluation.The sample was visually and physical evaluated as per specification with passing results, no leak/crack were detected on the discofix d500 4-way spin-lock.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.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number 400544962.One (1) unused sample with packaging was provided for evaluation.The sample was visually and physical evaluated as per specification with passing results, no leak/crack were detected.Based on the evaluation results, the reported defect was not confirmed.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: 13684748
• MDR Text Key: 287343983
• Report Number: 2523676-2022-00027
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• 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
• Device Lot Number: 21F08D9044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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