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

Model Number	4254503-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event 1 of b.Braun medical internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough investigation could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available, a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: event 1: in the nicu, a t connector separated from a yellow angiocath, resulting in blood leakage.This did not happen until a few days after the iv began running, so packaging with lot information was already discarded.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 9406030
• Report Number: 9610825-2019-00537
• Device Sequence Number: 16562122
• Product Code: DYB
• UDI-Device Identifier: 04046963318314
• UDI-Public: (01)04046963318314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 4254503-02
• Device Catalogue Number: 4254503-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1