MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG DISCOFIX®; STOPCOCK

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one used discofix 3-way stopcock blue ll in connection with a check valve without packaging.The provided sample was subjected to a visual examination.At the used sample the male luer lock cone of the connector is broken off.We assume that this damage is caused by an application problem, by too strong attachment at the lla connector.Please note: the cause for cracks or breaks could be high tensions in combination with disinfectants and / or certain drug ingredients (oil, alcohol, lipids etc.).A review of the batch and manufacturing records revealed no abnormalities or nonconformities.Therefore we consider the complaint not confirmed.The complaint is only taken to the knowledge and filed for statistical purpose.Note: this report is being filed for the product problem that occured.A second report, filed under mfr report number 9610825-2017-00227, was filed for the adverse event.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in france: stopcock-damaged-broken.Resulted in significant blood loss, and the patient had to receive a transfusion.

• Brand Name: DISCOFIX®
• Common Device Name: STOPCOCK
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7044732
• Report Number: 9610825-2017-00228
• Device Sequence Number: 16496690
• Product Code: FMG
• UDI-Device Identifier: 04046964183577
• UDI-Public: (01)04046964183577(17)200401(10)17D0192046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K760383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2017
• Report Date (Section F): 11/16/2017

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: 04/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4095111
• Device Lot Number: 17D0192046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/16/2017