MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT 60 ML SYRINGES LEUR LOCK TIP; SYRINGE, PISTON

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

Multiple monoject syringes are missing, the plunger.

• Brand Name: MONOJECT 60 ML SYRINGES LEUR LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 11131628
• MDR Text Key: 225779918
• Report Number: MW5098711
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 8881560125
• UDI-Public: 8881560125
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1