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

Model Number 4251687-02

Device Problems Fail-Safe Problem (2936); Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b. Braun medical inc. Internal report number (b)4). The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by the user facility: a nurse was stuck by one of the iv needles after the safety mechanism had been activated.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11215083
• MDR Text Key: 240738672
• Report Number: 9610825-2021-00001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4251687-02
• Device Catalogue Number: 4251687-02
• Device Lot Number: 20F27G8393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial