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

Catalog Number 456003

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample and lot number.Without the actual device and/or lot number, a thorough investigation could not be performed.Review of the discrepancy management system database was unable to be performed because the lot was reported as unknown.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.

Event Description

As reported by the user facility: leakage of chemotherapy during chemo embolization.No injuries reported.

• 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: 6828343
• MDR Text Key: 83946952
• Report Number: 2523676-2017-00123
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964183577
• UDI-Public: 04046964183577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/01/2017

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 Catalogue Number: 456003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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