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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION EXACTAMED; DISPENSER, LIQUID MEDICATION Back to Search Results
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).
 
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Brand Name
EXACTAMED
Type of Device
DISPENSER, LIQUID MEDICATION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key10294914
MDR Text Key199723966
Report NumberMW5095576
Device Sequence Number1
Product Code KYX
Combination Product (y/n)Y
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/17/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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