MAUDE Adverse Event Report: BD BD CONNECTA 3 WAY IV STOPCOCK; STOPCOCK, I.V. SET

Model Number 394910

Device Problem Defective Device (2588)

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

Event Date 11/04/2016

Event Type  malfunction  

Event Description

3 way iv stopcock did not allow user to push iv medications as device is intended, per pharmacist this is an ongoing issue with devices like this.

• Brand Name: BD CONNECTA 3 WAY IV STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 9295338
• MDR Text Key: 165631374
• Report Number: 9295338
• Device Sequence Number: 1
• Product Code: FMG
• 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: 10/10/2019,11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 394910
• Device Catalogue Number: 394910
• Device Lot Number: 6005989A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Date Report to Manufacturer: 11/08/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA