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

Model Number	4252519-02
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 10298818
• Report Number: 9610825-2020-00142
• Device Sequence Number: 14109376
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: 19N13G8274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1