MAUDE Adverse Event Report: 1000 ML GRADUATED CYLINDER; CONTAINER, LIQUID MEDICATION, GRADUATED

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Description

Hello - we have a safety concern that did not result in an error but it could cause errors, especially for pediatric patients.Staff noticed that our 1000 ml graduated cylinder has markings that are both ascending and descending in number.Reading the volume in the container on the wrong scale could result in an error in medication preparation such as oral suspension compounding in large quantities for a pediatric institution such as ours.The cylinder has a logo from marisco on it.We will notify (b)(6), the company that we used to purchase the graduated cylinder.Staff noticed that our 1000 ml graduated cylinder has markings that are both ascending and descending in number.We attempted to purchase a replacement 1000 ml graduated cylinder based on the product description in the healthcare logistics catalog and received an identical graduated cylinder with the same ascending and descending numeric scales.(b)(4).

• Brand Name: 1000 ML GRADUATED CYLINDER
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• MDR Report Key: 12780650
• MDR Text Key: 280711978
• Report Number: MW5105215
• Device Sequence Number: 1
• Product Code: KYW
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1