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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGES
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SYRINGES Back to Search Results
Device Problem Output Problem (3005)
Patient Problem Rash (2033)
Event Date 01/01/2015
Event Type  Other  
Event Description
My son was prescribed amoxicillin 400mg/5ml, dose 5ml, twice per day for 10 days.I filled this prescription at pharmacy.The bottle of amoxicillin was empty after 9 days (or 18 doses).The prescription was for 10 days (or 20 doses).I notified pharmacy on (b)(6) 2015.The pharmacist stated that the amoxicillin bottle is pre-filled with 100ml from the mfr.My concern was that the concentration was higher than prescribed, as the total amount given was only 90ml or that my child was under-dosed.The pharmacist checked and my son was still within a safe dose range for his weight, even if the concentration was higher and in 90ml.It is unk if the concentration was higher than expected from the mfr or if the concentration was as prescribed, just missing the other 10 ml in volume.I used the syringe as provided by pharmacy to deliver this medication to my son and no medication was wasted.The other thought is that perhaps the syringe supplied is inaccurate.Perhaps the 5ml mark is not truly 5ml.I have yet to check this but have saved the syringe.I have been a pediatric rn for 10 years and am an expert in drawing up and delivering medications.This was not due to human error on the part of the parent giving the medication.My son obtained a rash after the first dose, which required us to hold a dose and return the next am to be assessed by our provider.It was questionable at the time whether it was from the medication or scarlet fever.My son continued to take the amoxicillin per the provider, with no worsening rash or symptoms.On a side note, this same child was prescribed amoxicillin in (b)(6) 2015 which was filled at pharmacy as well and was also short 1 dose.I believe there is something wrong on the part of pharmacy, its bottle, or its syringes.While this did not affect my child in a negative way that we are aware of at this time, there is potential for harm for other children being given higher concentrations of medications than what were ordered or by being under-dosed.How prescription filled: electronic prescription sent directly to the pharmacy (by computer) from my doctor's office.(b)(6).Outcome: nothing/no harm.Where did the error occur: (b)(6) pharmacy.
 
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Brand Name
SYRINGES
Type of Device
SYRINGES
MDR Report Key5455025
MDR Text Key39012775
Report NumberMW5060424
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/23/2015
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/19/2016
Type of Device Usage N
Patient Sequence Number1
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