MAUDE Adverse Event Report: COVIDIEN MONOJECT SYRINGE

Device Problems Component Missing (2306); Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

When attempting to flush patient's iv, the nurse felt more resistance than usual.When she looked at the 10ml syringe, it was pulled back and empty, which the rn said it came directly out of the package in that condition.It was possible a small amount of air (icc or less) could have been injected when the rn felt the resistance and removed the flush from the pt's iv.The rn did not save the syringe, however all available lot numbers in stock on the clinical area were noted.(lot numbers available at the time of event were: 3127707, 3127461, 3128268, 3127211, 3127511, 3128033, 3127214.

• Brand Name: MONOJECT SYRINGE
• Type of Device: MONOJECT SYRINGE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6053723
• MDR Text Key: 58402556
• Report Number: MW5065583
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 75