MAUDE Adverse Event Report: HTL-STREFA, INC. DROPSAFE 3ML SYRINGE 25G X 1" SAFETY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	6065
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dropsafe 3ml syringes being used to inject janssen covid-19 vaccine treatment under emergency use authorization (eua): reporting this for device only (syringe/needle combination).Similar report was filed for two syringes of the same lot that were discovered on (b)(6) 2021 to be defective and were reported on 4/08/2021.This is for three additional syringes that were part of the supply to be used at a vaccination clinic on (b)(6) 2021 by (b)(6).Previously, we had a syringe/needle combination leak/come apart while it was being injected into a patient the previous week.A separate vaers report was filed for that event.When securing the needle to the syringe, the needle does not firmly lock into place and can continue to be rotated without there being a secure connection.We have previously experienced this many times before and have discarded many syringes from this manufacturer prior to use (different lots/products) without it being reported to medwatch.Other relevant information on label: (b)(4), lot 0325250004 2025-12-01.Fda safety report id# (b)(4).

• Brand Name: DROPSAFE 3ML SYRINGE 25G X 1" SAFETY NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA, INC.
• MDR Report Key: 11663651
• Report Number: MW5100739
• Device Sequence Number: 2999682
• Product Code: FMI
• UDI-Device Identifier: 85907996099210
• UDI-Public: (01)85907996099210
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/10/2021
• 3 Devices were Involved in the Event: 1 2 3

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: 12/01/2025
• Device Catalogue Number: 6065
• Device Lot Number: 0325250004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1