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

Model Number N/A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(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 Description

(b)(4): stopcock-damaged-broken.Resulted in significant blood loss, and the patient had to receive a transfusion.

• Brand Name: DISCOFIX®
• Type of Device: STOPCOCK
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown 18109 ; 4842408332
• MDR Report Key: 7044732
• MDR Text Key: 93191888
• Report Number: 9610825-2017-00228
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 04046964183577
• UDI-Public: (01)04046964183577(17)200401(10)17D0192046
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2017
• Distributor Facility Aware Date: 11/15/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2017
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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
• Patient Outcome(s): Required Intervention