MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) NEOMED ENFIT ORAL SYRINGES; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number BA-S05NC

Device Problems Fluid/Blood Leak (1250); Volume Accuracy Problem (1675); Defective Device (2588); Air/Gas in Device (4062)

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

Event Type  Injury  

Event Description

The neomed enfit 0.5ml and 1ml oral syringes are defective, causing oral solutions to leak past the rubber seal.This issue seemed to be recurrent with different lot numbers and has been ongoing since (b)(6) 2021.The defect has not been resolved yet, even after the issue was reported to the manufacturer and defective samples were sent back to the manufacturer for investigation in june 2021.The manufacturer has denied other reports of this issue and continued to encourage use of the defective syringes, even though the same issue has already been reported to the fda in january 2020.The leakiness varies between different viscosities of oral medication.Here is a sample of the number of syringes that leaks: ferrous sulfate 0.5 ml syringe: 23 out of 32 leaked; sodium chloride 1 ml syringe: 10 out of 16 leaked, 0.5 ml syringe: 9 out of 12 leaked; folic acid 0.5 ml syringe: 6 out of 8 leaked; spironolactone/hydrochlorothiazide 0.5 ml syringe: 1 out of 8 leaked; caffeine citrate 1 ml syringe: 0 out of 13 leaked; vitamin e 1 ml syringe: 2 out of 4 leaked.In addition, when capping the oral syringe, the plunger pushes down anywhere from 0.01 to 0.07 ml, creating air bubbles, even when the moat is free of fluid.This makes it very hard as a pharmacist to check the syringe to ensure the volume is accurate.The amount that pushes down when capping the syringe varies with different viscosities of fluid.Furthermore, when fluid is drawn into the 0.5ml syringe, regardless of whether or not the syringe is leaky, the space between the white part of the plunger tip and the barrel is not always completely filled.The fluid then slowly seeps into this space, causing the total dispensable volume to decrease by the time the medication is administered.The medication volumes for our neonatal patient population are very small (as small as 0.04 ml), so a leak of 0.01-0.05 ml is often profound and is a serious concern for patient safety.

• Brand Name: NEOMED ENFIT ORAL SYRINGES
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 16379658
• MDR Text Key: 309746781
• Report Number: MW5114947
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/10/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BA-S05NC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention