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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOMED, INC. NEOMED- NEOCONNECT; MEDICATION SYRINGE

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NEOMED, INC. NEOMED- NEOCONNECT; MEDICATION SYRINGE Back to Search Results
Model Number 1 ML ORAL ENFIT SYRINGE
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2020
Event Type  malfunction  
Event Description
Rn pulled patient's meds from omni drawer.At this time, rn noticed that patient's furosemide dose (3.6 mg = 0.36 ml) (drawn up in a 1 ml purple enfit oral syringe) had leaked past the plunger at the bottom of the syringe, leaving a large air bubble at the top of the syringe.Enough medication leaked out of the syringe that the there was only 0.30 ml of the medication left, leaving an inadequate dose.Rn contacted pharmacy about the issue and reordered the medication.At 20:50, rn received new dose of furosemide from pharmacy via the p tube.This time the medication was sent in a 0.5 ml purple enfit oral syringe, but rn noticed the same issue had occurred.Medication had leaked past the plunger, leaving a smaller dose than intended (0.31 ml).Rn was able to combine the two doses of furosemide (both doses had same concentration 10 mg/ml) to administer the correct dose (0.36 ml) to pt (in orange neoconnect enfit oral syringe).At 21:05, rn contacted pharmacy again in regards to the leaking enfit oral syringes.Pharmacy, at first thinking rn was reading syringe incorrectly, requested to show rn how to read the oral syringes.Rn offered to present the syringes to pharmacy and pharmacy agreed.Rn brought both oral syringes to pharmacy where the pharmacists confirmed that the syringes had in fact leaked past the plunger.Syringes were left with pharmacist, who stated they would contact the proper individuals to report the issue.Rn also notified and sent a picture of syringes to educators.An hour later, rn administered medication to patient with no further issues.
 
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Brand Name
NEOMED- NEOCONNECT
Type of Device
MEDICATION SYRINGE
Manufacturer (Section D)
NEOMED, INC.
100 londonderry ct
suite 112
woodstock GA 30188
MDR Report Key9792557
MDR Text Key182152137
Report Number9792557
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1 ML ORAL ENFIT SYRINGE
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2020
Event Location Hospital
Date Report to Manufacturer03/05/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2020
Type of Device Usage N
Patient Sequence Number1
Patient Age120 DA
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