ORAL MEDICATION SYRINGE UKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for ORAL MEDICATION SYRINGE UKNOWN manufactured by Unknown But Had A Cvs Logo On Barrel Of Syringe.

Event Text Entries

[177632657] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092707
MDR Report Key9659268
Date Received2020-01-31
Date of Event2020-02-01
Date Added to Maude2020-02-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORAL MEDICATION SYRINGE
Generic NameDISPENSER, LIQUID MEDICATION
Product CodeKYX
Date Received2020-01-31
Model NumberUKNOWN
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN BUT HAD A CVS LOGO ON BARREL OF SYRINGE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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