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

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).

• Brand Name: ROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• MDR Report Key: 14488786
• MDR Text Key: 292816835
• Report Number: MW5109889
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1468-2006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening