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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE

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HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE Back to Search Results
Model Number 23G X 3ML
Device Problems Leak/Splash (1354); Dull, Blunt (2407); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
Manufacturer Narrative
Based on analysis and conducted measurements some exceedances on parameter responsible for correct connections between safety needle and syringe were observed, but a reason of defect can be unrelated to the manufacture. A reason of correct connections between safety needle and syringe may be resulted by misuse. Additionally, accordingly to conducted empirical test based on instruction for use, if the safety needle is firmly seated on syringe as it is recommended by ifu and connection is verified by the user, then no problem with proper connection should occurred. We underline the necessity to following proper use as it shared on ifu from safety syringe to avoid problem connected the needle between the syringe. Regarding leakage on the plunger side, a leakage test was performed: water was draw into the syringe, needle tip was blocked by the gasket and the plunger was pushed in purpose to create the pressure and check the leakage issue. As the result no water leakage occurred. Regarding dull needle and bent needle from the user end, the puncture force test was made and rigidity test accordingly to iso 7864. All needles passed the test. Additionally, needle tip were observed under magnification. No hooks, burrs or damages of were observed. No deviations were observed. Regarding the blue safety caps breaks off when user attempts to cover the needle, an activation test was made. No deviations were observed. Each attempt succeeded.
 
Event Description
Reporter reported 6 needlesticks from drop safe brand due to poor engagement of safety mechanism. Problems identified by multiple vaccine sites leakage. The luer lock mechanism doesn't always seal the connection between the needle and syringe well enough to prevent leaking. Needle falls off the syringe due to poor quality of luer lock connection. Needles are noticeably dull causing difficulty piercing the skin resulting in patient complaints. Needles bend very easily when drawing up vaccine from the vial. Safety mechanism often seems to be engaged, but is not.
 
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Brand NameDROPSAFE SYRINGE WITH SAFETY NEEDLE
Type of DeviceSYRINGE WITH SAFETY NEEDLE
Manufacturer (Section D)
HTL-STREFA S.A.
adamowek 7
ozorkow, 95-03 5
PL 95-035
Manufacturer (Section G)
HTL-STREFA S.A.
adamowek 7
ozorkow, 95-03 5
PL 95-035
Manufacturer Contact
aleksandra prazmowska-wilanowska
adamowek 7
ozorkow, 95-03-5
PL   95-035
MDR Report Key11684968
MDR Text Key250271747
Report Number9613304-2021-00010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K170651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number23G X 3ML
Device Catalogue Number6053
Device Lot Number032350009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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