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

Model Number 23G X 3ML

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.It suggests: before use, when rotating the safety needle to the syringe, the safety needle should be push in the direction to the syringe, in that case, the hub of safety needle will be rotated into deeper position of spiral line of luer lock, then the needle won't be separated from the syringe.

Event Description

The end user reported that the needle and syringe hub would not tighten and comes off when the cap is removed.

• 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: 11573643
• MDR Text Key: 244390386
• Report Number: 9613304-2021-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• 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: 323250006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• 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: Initial
• Patient Sequence Number: 1