MAUDE Adverse Event Report: COVIDIEN (CARDINAL) / CARDINAL HEALTH 200, LLC. MONOJECT 60ML SYRINGE; SYRINGE, PISTON

Catalog Number 8881560125

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

There appears to be an excess of silicone lubricant on our 60ml monoject syringe plungers from covidien (cardinal).Fda safety report id# (b)(4).

• Brand Name: MONOJECT 60ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN (CARDINAL) / CARDINAL HEALTH 200, LLC.
• MDR Report Key: 12681613
• MDR Text Key: 278158762
• Report Number: MW5104842
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8881560125
• Device Lot Number: 112506X
• 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