MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 4-WAY STOPCOCK; TUBE, TISSUE CULTURE

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

When tightening 3-way stop cock (because 3 in a row were not aligned it looked like one may be lose) luer lock part of stop cock broke off remaining on attached stop cock.

• Brand Name: 4-WAY STOPCOCK
• Type of Device: TUBE, TISSUE CULTURE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 9610399
• MDR Text Key: 175673244
• Report Number: 9610399
• Device Sequence Number: 1
• Product Code: KJG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1