MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC MONOJECT SYRINGE; SYRINGE, PISTON

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Hello i have identified what i feel is a safety issue.I had a patient today tell me she draws her methotrexate injection up to the "10" on the syringe.This is a 25 mg/ml injectable product; 10 ml seemed like a lot to me.This would require 5 vials to give a sq dose (250 mg).We don't even give this high of dose to our it mtx adult patients.I asked the patient to tell me what she draws up to on the syringe and again she was adamant that its the "little 10".She didn't know her dose in mg.I told her i would call the clinic to find her right dose.As i was looking into it more, the only syringe i could think of small enough with whole numbers on it was an insulin syringe.Immediately i was concerned that she was using an insulin syringe and drawing to the 10 and only getting 0.1 mls.What i actually discovered is that the clinic ordered her "tb" syringes.I googled pictures of these and found this med safety issue! i will attach pictures.I determined she was drawing up the right dose of 1 ml but since the syringe says "1.0" she thought she was drawing to the "10".If this hadn't been looked into and just put on the med rec as 10 ml, this patient could have had a 10 fold overdose on her chart.I was a little shocked that these syringes can have no leading zeros and a trailing zero which can lead to significant dosing issues.There are a lot of different manufacturers that i saw but notably the ones we carry are bd and cividien monoject which are pretty reputable medical suppliers.I feel the way these syringes are marked have the definite potential to cause dosing errors.I was able to verify and place the dose in mg on the patient's chart and educate the patient that she is actually drawing up to a 1 ml mark and that her dose is 1 ml we are reporting to (b)(6) in hopes that the manufacturers can be requested to change the way they label their syringes to improve patient safety.Type: non medication error.Contributing factors: leading zero trailing zero mfr / labeler confusing / incomplete info (label / labeling) packaged measuring device cause for error poor product design: (i.E., vial, syringe, bag).Special code: mfr corrective action.Severity: circumstances or events have capacity to cause error.(b)(6).(b)(4).

• Brand Name: MONOJECT SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC
• MDR Report Key: 12377095
• MDR Text Key: 269519064
• Report Number: MW5103522
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/13/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1