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

Model Number 8600-01101

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.

• Brand Name: CURAPLEX EPI-SAFE SYRINGE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): SARNOVA INC. / BOUND TREE MEDICAL, LLC / BEMS HOLDINGS, LLC
• MDR Report Key: 8208617
• MDR Text Key: 132221126
• Report Number: MW5082738
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8600-01101
• Was Device Available for Evaluation?: No Answer Provided
• 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