MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD POSIFLUSH 10ML SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number DGL213706 500040842

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2020

Event Type  malfunction  

Event Description

Bd posiflush saline syringe does not flush easily.We have had several syringes that do not flush past 8 ml and two that do not flush pass 5ml.Even when disconnected from iv the syringe does not flush.In two instances this required pts to be poked a second time, thinking the iv was not functioning.Fda safety report id# (b)(4).

• Brand Name: BD POSIFLUSH 10ML SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON & CO. ; franklin lakes NJ 07417
• MDR Report Key: 9596126
• MDR Text Key: 175697762
• Report Number: MW5092285
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: DGL213706 500040842
• Device Lot Number: 9274701
• Was Device Available for Evaluation?: Yes
• 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