MAUDE Adverse Event Report: LUER-LOCK PREFILLED SYRINGE; SYRINGE, PISTON

Device Problems Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Type  No Answer Provided  

Event Description

Emergency epinephrine dosing error an infant that was found down at home was transported to a community hosp emergency room in cardiac arrest.Per standard practice, a broselow tape was utilized for guidance.The pt was determined to be in the 6 - 7 kg (pink) range.Based on the broselow tape, a dose of 0.65 ml epinephrine (0.065mg of 1:10,000 concentration) was ordered.The 10 ml emergency syringe is marked in both mg and mls in 1 ml increments, with an unmarked midpoint graduation line.A dose of "point six five" was communicated to the nurse administering the epinephrine.The nurse incorrectly read the syringe and administered 0.65 mg (6.5 ml).Near the end of code, a pharmacist identified the dosing error after the code team ran out epinephrine and requested a resupply.Several product design, and even protocol design, changes may have contributed to this error: the ams epi syringe has two sets of numbers, and units of measure do not immediately trail the number but instead are very small on the top of the syringe.This led to confusion / misinterpretation of the dose.Our organization previously stocked pfizer's syringe which is only marked with ml on the syringe and likely contributed to the staff's misinterpretation; it is not possible to dose 0.65 mls accurately with the current syringe design.Even attempts to do so, are inaccurate.Https://jamanetwork.Com/journals/jamapediatrics/article-abstract/2604748 and, on average, lead to a two fold dosing error; the broselow tape gives dosing directions in both mls and mgs, while giving the concentration in ratio expressions; although ismp recommends against labeling with ratio expressions, e.G."1:10,000", http://www.Ismp.Org/newsletters/nursing/issues/nurseadviseerr201512.Pdf.Some well-known protocols still refer to them - as in this case; a pediatric emergency syringe could have prevented this error as the largest dose on the broselow tape is less than 4 mls.Medication administered to or used by the pt? yes.Where did the error occur? hospital; hospital unit: emergency dept; type of staff made initial error? nurse; when and how was error discovered? near the end of the code, a pharmacist identified the dosing error after the code team ran out of epinephrine and requested a resupply.Level of staff who discovered the error? pharmacist.Pt counseling provided? unk.Ismp, (b)(6).Error resulted in increased pt monitoring; no pt harm.

• Brand Name: LUER-LOCK PREFILLED SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 8194436
• MDR Text Key: 131890566
• Report Number: MW5082555
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 7