BROSELOW TAPES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for BROSELOW TAPES manufactured by Unk.

Event Text Entries

[141321885] Hello. When the broselow tapes were announced for a new release (2017 edition), we immediately began to plan for them and ordered our products. When we received them, and looked at them, we had several concerns. The new tapes include drug concentrations, which for thoroughness is a great addition. However with drug shortages and drug availability in general, this creates an opportunity for error. Previous versions did not include the concentration and volume of medication to be administered, only the dose in milligrams or micrograms depending on the drug. In the past, due to the low volume nature of pediatric pts and the concern for availability of info, we created a drip chart for the nursing staff that included the drug stocked on the cart and the volume needed. These charts hang on the outside of the cart and are a larger font for the nurse drawing up medications to see. Now, with the new tapes, there are times the product we carry is not one of the multiple concentrations listed (for example magnesium sulfate). We have done several strategic sessions to try to orient the staff to this issue, and updated our drip charts with the highlighted concentrations that we stock. However, we still see confusion with this issue. Thank you. (b)(4), email: [email protected], access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085642
MDR Report Key8491883
Date Received2019-04-05
Date of Report2019-04-05
Date Added to Maude2019-04-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBROSELOW TAPES
Generic NameTAPES, MEASURING, RULERS AND CALIPERS
Product CodeFTY
Date Received2019-04-05
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-05

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