MAUDE Adverse Event Report: BECTON DICKINSON; SYRINGE, PISTON

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

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

Event Date 10/15/2019

Event Type  malfunction  

Event Description

Clindamycin in a three milliliter syringe dose given per alaris pump.Fluid noted below pump after infusion.Resident notified.This report is being submitted for tracking purposes.Infusion was in the neonatal intensive care unit.

• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 9309312
• MDR Text Key: 165988532
• Report Number: 9309312
• Device Sequence Number: 1
• Product Code: FMF
• 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: 11/05/2019,10/29/2019

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: 11/05/2019
• Date Report to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1