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

Model Number 456020

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2020

Event Type  malfunction  

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.

Event Description

As reported by the user facility: "rn noticed after daily lines were changed, leaking from infant's umbilical venous catheter (estimate of 20 minutes after lines were changed).There was a back flow of the infant's blood through the line and a mixture of blood & fluid were noticed on the infant's linen (approximately 2 inches in diameter).Leaking noted from stopcock at the connection where new fluids were inserted.Using sterile technique, rn removed stopcock from line setup.Line no longer leaking after removal.After flushing the stopcock, leaking noted due to a crack at clc insertion site along seam of the stopcock.Neo-team aware of incident." no injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).  based on the data from the investigation we are unable to determine the root cause of the reported incident via the photo.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
• MDR Report Key: 10132697
• MDR Text Key: 194538058
• Report Number: 2523676-2020-00154
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 456020
• Device Catalogue Number: 456020
• Device Lot Number: 19D1192041
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1