MAUDE Adverse Event Report: UNKNOWN BUT HAD A CVS LOGO ON BARREL OF SYRINGE ORAL MEDICATION SYRINGE; DISPENSER, LIQUID MEDICATION

Model Number UKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Event Description

I am writing to you on the recommendation of a staff member at (b)(6).My grandson was diagnosed with a bilateral wear infection on (b)(6) and was ordered an oral antibiotic.That prescription was filled by a (b)(6) pharmacy at (b)(6).An oral medication syringe was included with the antibiotic.Approximately one week later while i was visiting my grandson, my daughter showed me the conditions of the oral medication syringe.Because the prescription was in a sugary suspension, she washed the syringe in a warm soapy water.After the first washing, the black dosing demarcation lines were smeared or missing and the words ¿(b)(6) pharmacy¿ written on the barrel of the syringe were recognizable.I told her i would like to show this to the pharmacist at (b)(6) and i did so the following morning.On (b)(6) at approximately 10:15 am, i reported my concerns to a pharmacist at the dispensing pharmacy.Her response was very disappointing.She proceeded to tell me the syringe was designed for single use only and was not intended to be washed.My daughter states that she picked this prescription up at the drive-thru window and she was never informed about this.I explained to the pharmacist that unless (b)(6) provided 20 such syringes for the duration of the antibiotic course, it was unrealistic and unhygienic for a parent to not wash a syringe containing a sticky sugary suspension.No one would use a spoon for 20 meals without washing it.When i told her that i believed that such a product could result in dosing errors and was therefore unsafe, she responded ¿i would not even know who to report this to¿ at that point i realized that continuing the conversation with her was futile.I am a retired family nurse practitioner and an experienced emergency room nurse and i have seen first-hand how easily dosing errors can happen and how dangerous they can be, particularly in a pediatric population.Fortunately, no harm came to my grandson.However, i still believe this product is unsafe and should be removed from circulation immediately.It should be noted that some other manufacturer¿s oral medication syringes are safe to wash and re-use, liquid infant tylenol being a perfect example.It is my hope the fda can use its resources to investigate and demand removal of this product.

• Brand Name: ORAL MEDICATION SYRINGE
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): UNKNOWN BUT HAD A CVS LOGO ON BARREL OF SYRINGE
• MDR Report Key: 9659268
• MDR Text Key: 177632657
• Report Number: MW5092707
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UKNOWN
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 18