MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BECTON DICKINSON 10CC PRE FILLED SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Device Problem Difficult to Flush (1251)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Per protocol this rn went to flush patient's mediport with normal saline and then heparin lock.At first, when flushing mediport with the prefilled normal saline bd 10cc syringe there was no resistance, blood return obtained post infusion and went to finish flushing with this same normal saline syringe when hit resistance.Syringe removed and new prefilled normal saline syringe used on mediport and flushed easily.Fda safety report id # (b)(4).

• Brand Name: BECTON DICKINSON 10CC PRE FILLED SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON & CO.; franklin lakes NJ 07417
• MDR Report Key: 11783127
• MDR Text Key: 249482825
• Report Number: MW5101198
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1