MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD POSIFLUSH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 306546

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/12/2022

Event Type  malfunction  

Event Description

These flushes are very difficult to flush.The plunger appears to be getting stuck.This is causing nurses to replace iv lines when it is not actually needed.When they use another lot#, the iv flushes fine.

• Brand Name: BD POSIFLUSH
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 14773086
• MDR Text Key: 294504443
• Report Number: 14773086
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1244145
• 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: 06/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1