MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE 25G X 3ML

Model Number 25G X 3ML

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

The three users were injured when the safety device on your needles failed and they were pricked with used needles.The users were made blood test an they was (b)(6).

• Brand Name: DROPSAFE SYRINGE WITH SAFETY NEEDLE 25G X 3ML
• Type of Device: SYRINGE WITH SAFETY NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 12743168
• MDR Text Key: 279816968
• Report Number: 9613304-2021-00030
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K171982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25G X 3ML
• Device Catalogue Number: 6055
• Device Lot Number: 0325250004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• 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