MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH; SALINE FLUSH SYRINGE

Catalog Number 306546

Device Problem Particulates (1451)

Patient Problem No Information (3190)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

There was a normal saline flush syringe with particulates in the solution.

• Brand Name: BD POSIFLUSH
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 4568540
• MDR Text Key: 5472460
• Report Number: 4568540
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 306546
• Device Lot Number: 4349738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1