MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH MONOJECT 60ML LL SYRINGE; SYRINGE, PISTON

Model Number	1186000777
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Covidien monoject 60ml ll syringes-the syringe tip breaks off of the syringe when drawing up medication resulting in spills.This is happening while making hazardous compounds (chemo) as well as non-hazardous.There also is no expiration date on the sterile syringe.Fda safety report id # (b)(4).

• Brand Name: MONOJECT 60ML LL SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH; mansfield MA 02048
• MDR Report Key: 13561073
• Report Number: MW5107566
• Device Sequence Number: 4673930
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: (01)10884521010864
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 118212X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown