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 Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2019
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
As reported by user facility: set detached and patient lost 2 ml of blood.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Two (2) samples were received for evaluation.The samples were subjected to leakage testing, and no leakage was observed.The returned devices met requirements according to specification.If additional information becomes available, a follow up report will be submitted.

• 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: 9418770
• Report Number: 9610825-2019-00542
• Device Sequence Number: 11368598
• 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,Followup
• Report Date (Section B): 01/28/2020

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 Model Number: 4254503-02
• Device Catalogue Number: 4254503-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1