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

Lot Number 0335963

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

Patient Problem Insufficient Information (4580)

Event Date 02/27/2021

Event Type  No Answer Provided  

Event Description

Bd 10cc normal saline flush with resistance, not operating as intended.Manufacturer response for normal saline flush, (brand not provided) (per site reporter).Information submitted to bd sales rep.Company requested and we sent samples of the defective lots to company.

• 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: 11912163
• MDR Text Key: 253511679
• Report Number: 11912163
• 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: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 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: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1