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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 07/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received one used discofix-3 blau 2ver ms without packaging.Moreover we received 3 bionecteur valves, mounted on an octopus 3 line of the competitor vygon.The provided samples were taken to a visual inspection.Damages or manufacturing faults were not detected.In addition, the lock connection between the discofix 3-way stop cock (lla-cone) and the bionecteur valves (lli-cone) was manually tested.It was possible without any difficulties to connect the discofix 3-way stop cock with the bionecteur valves.An easily loosening of the connection could not be detected.A disconnection was also possible without any difficulties.Furthermore, the discofix 3-way stop cock was connected with the bionecteur valves and taken to a functional test in connection with a 10 ml omnifix luer lock syringe and nacl 0.9%.It was not possible to inject liquid through the discofix 3-way stop cock respectively through the bionecteur valves in assembled condition.In addition, the functional test was repeated but without discofix 3-way stop cock (omnifix luer lock syringe was directly mounted on the bionecteur valves).It was very difficult to inject liquid with the omnifix syringe through the bionecteur valves.Afterwards, the discofix 3-way stop cock was tested for blockages in connection with the omnifix luer lock syringe and nacl 0.9%.Blockages were not detected.The liquid could be injected through the discofix 3-way stop cock without any difficulties.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): stopcock-connection-compatibility.

Manufacturer Narrative

(b)(4).The manufacturing documentation is complete.No irregularities or abnormalities were documented in the in-process checks and quality records.The machine papers/logbooks have been checked.There are no entries which can be associated with the fault.

• 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5893336
• MDR Text Key: 52643800
• Report Number: 9610825-2016-00565
• Device Sequence Number: 1
• Product Code: FMG
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2016,07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Model Number: N/A
• Device Catalogue Number: 4095111
• Device Lot Number: 16D1092041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2016
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2016
• 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): Other