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

Catalog Number 456020

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although it was confirmed that the device involved is not available for further evaluation, a picture was provided and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: customer reports blue handle is falling of stopcock in use on arterial line.Occurred while respiratory therapist obtaining blood gas.When blue handle fell off blood poured out of line, therapist was able to block stopcock until new one obtained.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned in connection with this complaint.However, a picture of a stopcock was returned.Visual inspection of the returned picture noted blood in the stopcock.However, there are no signs of the product to be leaking.No conclusions can be made in regards to the returned photo.Further investigation of the complaint is not possible without a sample.The reported defect cannot be confirmed.A 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 a sample and/or 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
• MDR Report Key: 8253283
• MDR Text Key: 133321492
• Report Number: 2523676-2018-00117
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: 04046964996962
• Combination Product (y/n): N
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 456020
• Device Lot Number: 18F1492044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1