MAUDE Adverse Event Report: COVIDIEN / / CARDINAL HEALTH MONOJECT; SYRINGE, PISTON

Model Number 1186000777

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

Monoject 60ml ll syringe - noted a piece of plastic adhered to the black plunger face.Lot:122126x.Fda safety report id # (b)(4).

• Brand Name: MONOJECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN / / CARDINAL HEALTH
• MDR Report Key: 12648807
• MDR Text Key: 277400145
• Report Number: MW5104679
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 122126X
• 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