MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SAFETY NEEDLE 25G X 1ML; SYRINGE WITH SAFETY NEEDLE

Model Number	DROPSAFE SAFETY NEEDLE 25G X 1ML
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The safety needle does not close properly or all the way so it is a hazard for our employees.We did have a recent needle stick in the clinic but medical attn was not required.

• Brand Name: DROPSAFE SAFETY NEEDLE 25G X 1ML
• Common Device Name: 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: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 14883790
• Report Number: 9613304-2022-00007
• Device Sequence Number: 14749780
• Product Code: FMF
• UDI-Device Identifier: 85907996099319
• UDI-Public: (01)85907996099319(17)260401(10)SN25250018
• Combination Product (Y/N): N
• PMA/510(K) Number: K170651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: DROPSAFE SAFETY NEEDLE 25G X 1ML
• Device Catalogue Number: 6059
• Device Lot Number: SN25250018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown