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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SARNOVA INC. / BOUND TREE MEDICAL, LLC / BEMS HOLDINGS, LLC CURAPLEX EPI-SAFE SYRINGE SYRINGE PISTON

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SARNOVA INC. / BOUND TREE MEDICAL, LLC / BEMS HOLDINGS, LLC CURAPLEX EPI-SAFE SYRINGE SYRINGE PISTON Back to Search Results
Model Number 8600-01100
Device Problems Nonstandard Device (1420); Off-Label Use (1494)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
The "epi-safe kit" is a combination product (drug+device) manufactured by curaplex (sarnova). The product appears to not be registered and uses a syringe that is not fda approved for dosing children, and off-label for drug induced in the kit (epinephrine). The product was recalled, however the mfr is instructing end-users to "refurbish" the kit themselves and to "not return" the kits or devices to the mfr. Moreover, the mfr has made it unclear and complicated for people to return the product (kit), (b)(6). This miscommunication, as well as a lack of clarity regarding the danger of this product (can be given wrong route and is the wrong dose for children "off-label"), has led to end-users holding on to these kits and saying there is nothing wrong with them, that the fda is in error and that they should be used on children, even mandating to use on children. (b)(6). The mfr should make the effort to take back these dangerous medical devices and faulty kits, to make sure no children are harmed by their off-label use. Dose or amount: 0. 15 mg, frequency: prn, route: intravenous. Diagnosis or reason for use: anaphylaxis. Is the product compounded? no; is the product over-the-counter? no.
 
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Brand NameCURAPLEX EPI-SAFE SYRINGE
Type of DeviceSYRINGE PISTON
Manufacturer (Section D)
SARNOVA INC. / BOUND TREE MEDICAL, LLC / BEMS HOLDINGS, LLC
MDR Report Key8208617
MDR Text Key132221126
Report NumberMW5082738
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/27/2018
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8600-01100
Device Catalogue Number
Device Lot Number
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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