MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT TUBERCULIN SAFETY SYRINGE 25 GX5/8 1ML; SYRINGE, PISTON

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The new syringes were placed into circulation; staff immediately identified the potential for confusion with insulin syringes which also have an orange cap.Orange cap tuberculin syringes were removed from general circulation and will only be available when administering a ppd.When contacting cardinal, we were told iso standards changed (iso standard 6009) and the cap color was now based on the gauge size of the needle.We are concerned about the 2 syringe types being the same color.Dispensing device involved inappropriate/inaccurate measuring device.Circumstances or events have capacity to cause error.(b)(6).See scanned pages.

• Brand Name: MONOJECT TUBERCULIN SAFETY SYRINGE 25 GX5/8 1ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 13720393
• MDR Text Key: 287001143
• Report Number: MW5107994
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1