MAUDE Adverse Event Report: NEOMED, INC. NEOMED ENFIT SYRINGES; ENTERAL SYRINGES WITH ENTERNAL SPECIFIC CONNECTORS

Device Problems Incorrect Measurement (1383); Defective Device (2588)

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

Event Type  No Answer Provided  

Event Description

We recently went live with neomed enfit syringes, replacing all legacy oral syringes.We have had multiple adverse events using the 0.5ml syringe.Neomed¿s syringe cap snaps/clicks onto the syringe displacing the volume of air of the cap into in the syringe which creates variability in dose measurement.Despite doing advance testing, we did not catch this issue until live use.We also have had significant challenges with plunger movement with the cap on the syringe, in some cases up tp 0.1 ml of plunger movement.In other words, the technician fills the syringe and leaves for pharmacist checking.The pharmacist comes to check and the plunger will depress below the dose.More often 0.02 to 0.07ml of plunger movement after the dose is measured.This occurs more often with the oily medications like ferrous sulfate.These issues did not occur with our legacy syringes.After meeting with neomed¿s senior engineer, he showed us detailed cad drawings and a test model of a new syringe cap that will dispel air as you cap syringe.This was not revealed to us prior to go live, after further testing we noticed the controlled substances had less problems because the tamper evident cap screws on and therefore less air is forced into the syringe.We found no more than 0.02ml variation after the cap was placed with tamper evident caps.Neomed is giving us tamper evident caps for free ((b)(6) each) until the new cap is ready.All along neomed speaks of how many hospitals have launched with their product but not sharing the safety concerns in dose measurement.I understand they are making their way through a challenging design process but their transparency has been lacking.I watched a presentation by neomed yesterday intended for hospitals interested in learning about transition to enfit and they did not mention the cap issue.(b)(6), access number: (b)(4).Dosage form: injectable.

• Brand Name: NEOMED ENFIT SYRINGES
• Type of Device: ENTERAL SYRINGES WITH ENTERNAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.
• MDR Report Key: 8206288
• MDR Text Key: 132492748
• Report Number: MW5082682
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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