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

Catalog Number 306553

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2018

Event Type  malfunction  

Event Description

Multiple supply of 10 ml prefilled sodium chloride syringes found all to be damaged by environment and not able to be used due to question of sterility compromise.

Event Description

Multiple supply of 10 ml prefilled sodium chloride syringes found all to be damaged by environment and not able to be used due to question of sterility compromise.

• Brand Name: BD POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 7298719
• MDR Text Key: 101078811
• Report Number: 7298719
• 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
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 306553
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1