MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Lot Number LOT# 0335963

Device Problems Difficult to Flush (1251); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

Normal saline flush with much resistance in syringe to flush even when not connected to any line.

• Brand Name: BD POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11900725
• MDR Text Key: 253178258
• Report Number: 11900725
• Device Sequence Number: 1
• Product Code: NGT
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: LOT# 0335963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1