MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT 3ML ENTRAL SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Catalog Number 8881103015

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Description

Covidien monoject 3 ml enteral syringe marking is confusing on their 1/2 ml, it is printed as (1/2, 2, 1/2, 3 ml) which can easily be misread and potentially lead to wrong medication dose / volume prepared and administered by pt.Advise the mfr to print as (1/2, 1, 1/1/2, 3 ml or 0.5, 1, 1.5, 2, 2.5, 3 ml) instead to avoid confusion and misreading.Poor product design: (i.E.Vial, syringe, bag) packaged measuring device cause for error "units" misunderstood.(b)(6).Submission id: (b)(4).

• Brand Name: MONOJECT 3ML ENTRAL SYRINGE
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 12814477
• MDR Text Key: 280936362
• Report Number: MW5105316
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 8881103015
• Device Lot Number: 930874
• Patient Sequence Number: 1