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

Model Number 306414

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Date 01/09/2019

Event Type  malfunction  

Event Description

While injecting heparin from the prefilled syringe into the patient's line during a blood drawing procedure fluid from the syringe splashed back into the nurses' eye.Patient is on oncology unit, but not other drugs or therapies could have contributed at the time of the event.

• Brand Name: BD POSIFLUSH
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 9122578
• MDR Text Key: 160163011
• Report Number: 9122578
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2019,01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306414
• Device Catalogue Number: 306414
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1