MAUDE Adverse Event Report: COVIDIEN COVIDIEN MONOJECT FLUSH SYRINGE, 10 ML FILL; SYRINGE, PISTON

Device Problems Gas/Air Leak (2946); Pressure Problem (3012)

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

Event Date 01/23/2020

Event Type  malfunction  

Event Description

A 10 cc prefilled flushes noted to have negative pressure which draws the fluid back into the syringe.The issue was originally noted while the rn was preparing for initiation of iv.She flushed the extension tubing (aka j loop) only to find that the fluid she previously placed into the j loop withdrew into the syringe.Therefore, the j loop was not filled with saline as expected, but air.Depending on pt size, an inadvertent bolus of air could cause harm.This issue was reproduced across various attempts with a variety of lot numbers.

• Brand Name: COVIDIEN MONOJECT FLUSH SYRINGE, 10 ML FILL
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9665562
• MDR Text Key: 177883991
• Report Number: MW5092727
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1