MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMED; DISPENSER, LIQUID MEDICATION

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Exactamed 3ml syringes for enteral meds from baxter, contain confusing markings, and marking labels that have led to multiple doses being prepared at the incorrect volume by pharmacy technicians.Doses were caught prior to being dispensed from the pharmacy.Feedback from pharmacy staff: not clear which line marking 'ml' is referring to; format of number and ml being stacked vs.Horizontally displayed adds to confusion; markings with no ml notation vs.Those with ml notation not significantly different enough to be clear which line ml notation is referring to.Medication administered to or used by the patient: no.When and how was error discovered: doses were caught prior to being dispensed from the pharmacy.Patient counseling provided: unknown.Relevant materials provided: image.Ismp, (b)(6), access number: (b)(4).

• Brand Name: EXACTAMED
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 10294914
• MDR Text Key: 199723966
• Report Number: MW5095576
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1