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

Catalog Number 306546

Device Problem Particulates (1451)

Patient Problem No Information (3190)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

Precipitate was found in the flush syringe.It was identified before use.This is second instance that this issue was identified.

• Brand Name: BD POSIFLUSH
• Type of Device: POSIFLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 4568548
• MDR Text Key: 5472463
• Report Number: 4568548
• 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: 02/18/2015

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: Invalid Data
• Device Catalogue Number: 306546
• Device Lot Number: 4349738
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRECIPITATE IN FLUSH SYRINGE. IDENTIFIED BEFORE IT; CAME IN CONTACT WITH ANY PATIENT.