MAUDE Adverse Event Report: VESCO MEDICAL VESCO MEDICAL 3 ML ENFIT LOW DOSE TIP SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number VED-603EO

Device Problems Device Markings/Labelling Problem (2911); Measurement System Incompatibility (2982)

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

Event Date 02/24/2023

Event Type  Injury  

Event Description

Beginning the transition to enfit supplies, it was noticed that the enfit 3 ml syringes do not measure the same amount of medicine as the baxter oral 3 ml syringes that i have used successfully for 18 years.This is regardless of medication collecting in the 'moat' area of the enfit fitting.That can easily be removed before administering.Upon comparing the contents of the 2.5 ml of medication drawn into a 3 ml oral syringe and 2.5 ml of the same medication drawn into a 3 ml enfit syringe, there was a difference of 0.5 ml.This is dangerous as the medication being drawn is a cardiac drug.I am at a loss as what to do as far as administering the correct dosage in an enfit syringe that the patient has been prescribed.I understand the danger of misconnections, but there is a great risk to patients on an everyday basis of the inaccurate dosing of critical medications in enfit syringes.

• Brand Name: VESCO MEDICAL 3 ML ENFIT LOW DOSE TIP SYRINGE
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): VESCO MEDICAL; 7795 walton parkway; ste 165; new albany OH 43054
• MDR Report Key: 16462083
• MDR Text Key: 310635742
• Report Number: MW5115345
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VED-603EO
• Device Catalogue Number: VED-603EO
• Device Lot Number: 211201
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: "CARDIAC DRUG"; BAXTER ORAL 3 ML SYRINGE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White