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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM SYSTEM/DEVICE, PHARMACY COMPOUNDING

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ROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 1468-2006
Device Problems Product Quality Problem (1506); Short Fill (1575); Device Markings/Labelling Problem (2911); Application Program Problem: Medication Error (3198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  Injury  
Event Description
Iv robot - smartfiller from cargin, llc in operation since 2018 fills iv syringes for patient use. Over the course of 4 years, the robot has created many near-miss situations that could potentially compromise patient safety. The device has the potential to under fill syringes, package and label syringes without any medications added. Has happened on multiple occasions. Other issues include syringes labeled with incorrect barcode, incorrect beyond use dates, and drug name all errors which have been caught prior to patient distribution. Vendor has been uncooperative with resolution. Cargin llc, (b)(4) us. Fda safety report id # (b)(4).
 
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Brand NameROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM
Type of DeviceSYSTEM/DEVICE, PHARMACY COMPOUNDING
MDR Report Key14488786
MDR Text Key292816835
Report NumberMW5109889
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1468-2006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/23/2022 Patient Sequence Number: 1
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