MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THE

Model Number 4252520-02

Device Problem Fluid/Blood Leak (1250)

Patient Problems Needle Stick/Puncture (2462); Blood Loss (2597)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the sample are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: immediately had blood coming out of puncture site.Attempted to aspirate blood and got air, able to hold down site and flush and aspirate blood.With second flush noted ns coming out of puncture site.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 8699238
• MDR Text Key: 148010987
• Report Number: 9610825-2019-00215
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963318178
• UDI-Public: (01)04046963318178
• Combination Product (y/n): N
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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 Model Number: 4252520-02
• Device Catalogue Number: 4252520-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1