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

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

Patient Problem Air Embolism (1697)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being filed for an item number that is not sold in the united states, however this item or similar items are used in products that are sold in the united states by b.Braun medical, inc.No sample has been returned for investigation.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.Additional attempts to receive the sample are being made.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.

Event Description

As reported by the user facility ((b)(4)): stopcock-air inlet.

Manufacturer Narrative

Exemption number e2016018.B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun (b)(4) (manufacturer).This report has been identified as b.Braun (b)(4) internal report # (b)(4).The received: one picture, no samples for investigation.The picture shows a used (contaminated with blood) intrafix safeset spinlock,180cm, pierced into a 1000 ml ecoflac nacl 0.9%.The intrafix is connected with a discofix-3-way stopcock red ll, different infusion lines and an infusion bag with blood.Based on the provided picture, it is not possible to determine a leakage or damage on the discofix-3.A review of the batch and manufacturing documentation could not be performed, as no batch number has been provided.We can only take note of the complaint and file it for statistical purpose.

• Brand Name: DISCOFIX®
• Type of Device: STOPCOCK
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7999531
• MDR Text Key: 124823379
• Report Number: 9610825-2018-00229
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4095120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2018
• Distributor Facility Aware Date: 10/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1