NEOMED ENFIT SYRINGES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-28 for NEOMED ENFIT SYRINGES manufactured by Neomed, Inc..

Event Text Entries

[132492748] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082682
MDR Report Key8206288
Date Received2018-12-28
Date of Report2018-04-06
Date Added to Maude2018-12-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNEOMED ENFIT SYRINGES
Generic NameENTERAL SYRINGES WITH ENTERNAL SPECIFIC CONNECTORS
Product CodePNR
Date Received2018-12-28
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEOMED, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-28

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