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

Model Number 455991

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device involved is not available for evaluation, 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: it was reported that during use of the product blood was coming out.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Without the actual device, a thorough investigation could not be performed.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 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: 9595924
• MDR Text Key: 177970737
• Report Number: 2523676-2019-00239
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964996986
• UDI-Public: 04046964996986
• Combination Product (y/n): N
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 455991
• Device Catalogue Number: 455991
• Device Lot Number: 18H3092045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1