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

Model Number 4252519-02

Device Problem Protective Measures Problem (3015)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).A photo was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the concern.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by user facility: when starting an iv catheter on an outpatient, the safety guard on the needle did not activate, leaving the needle tip exposed.I noticed as i was pulling the needle out and threading the catheter in and no contact was made with my body or patient's body.

• 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 ; 2408332
• MDR Report Key: 10298818
• MDR Text Key: 199995835
• Report Number: 9610825-2020-00142
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• 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
• Report Date: 07/20/2020

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: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: 19N13G8274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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