MAUDE Adverse Event Report: BECTON DICKINSON & COMPANY; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Upon doing a sterile line change, nurse noticed the syringe with lipids was leaking.Pharmacy was notified and a new tube was sent.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 10459498
• MDR Text Key: 204549882
• Report Number: 10459498
• Device Sequence Number: 1
• Product Code: FPA
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA