MAUDE Adverse Event Report: LUER LOCK SYRINGES; SYRINGE, PISTON

Device Problems Off-Label Use (1494); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Convulsion/Seizure (4406)

Event Description

A (b)(6) female patient was admitted for uncontrolled seizures.The patient is developmentally delayed and mom is the primary care provider.There were about 12 home medications that mom wanted us to use.Some were formulary, but mom was very concerned about excipients and patients allergies etc (reactions unknown).A handful of these are controlled substances too.The home medications were not in their prescription bottles.Some were tablets in luer lock syringe - mom adds water then gives tab in water(?).Some were uncapped liquids in luer locked syringe.Issue - mom is storing oral liquids in luer lock syringes, and tablets in luer lock syringes.Mom means well, and is likely overwhelmed and trying to create a process that 'works' for her, but introduces risks.Overworked (extra hours/days) improperly used (i.E., pump, device) inappropriate/inaccurate measuring device dispensing device involved patient error: patient uses drug incorrectly communication, poor/lacking (nonspecific) inappropriate/inaccurate measuring device improperly used (i.E., pump, device) overworked (extra hours/days) patient error: patient uses drug incorrectly; lack of patient counseling.(b)(4).

• Brand Name: LUER LOCK SYRINGES
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12878240
• MDR Text Key: 281438011
• Report Number: MW5105604
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1