MAUDE Adverse Event Report: UNKNOWN GRADUATED CYLINDER BY EZY DOSE; CONTAINER, LIQUID MEDICATION, GRADUATED

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

Event Type  Other  

Event Description

Incorrect amount of water given per bottle of amoxicillin 2-100ml bottles.Technician measured 30ml per bottle due to the graduated cylinder having confusing measurements but should have been 70ml per bottle.The graduated cylinder by ezy dose has 2 separate measurements on each side of the graduated cylinder one side is ascending graduation the other side is descending numbers-.Gave patient new bottles with correct measurements.New graduated cylinders ordered today xx/xx/23 to decrease the chance of this occuring again.This new graduated cylinder has only one set of measurements.(b)(6).Submission id (b)(4).

• Brand Name: GRADUATED CYLINDER BY EZY DOSE
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18384484
• MDR Text Key: 331359477
• Report Number: MW5149490
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN FOR ORAL SUSPENSION.