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

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.

• Brand Name: DROPSAFE SYRINGE WITH SAFETY NEEDLE
• Type of Device: SYRINGE 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 Key: 11684968
• MDR Text Key: 250271747
• Report Number: 9613304-2021-00010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K170651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 23G X 3ML
• Device Catalogue Number: 6053
• Device Lot Number: 032350009
• Was Device Available for Evaluation?: No
• 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: Unknown
• Patient Sequence Number: 1