MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 0323250006

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2021

Event Type  malfunction  

Event Description

Dropsafe syringe 3ml 23gx 1" treatment under emergency use authorization (eua): hub and syringe did not securely fit together.The needle included in the package would not tightly twist into the syringe.Attempting to tighten the needle resulted in the needle remaining loosely attached to the syringe.Utilizing a different needle with the provided syringe resulted in a tight fit.Alternatively, utilizing a different syringe with the provided needle resulted in a tight fit.It appears as though the issue is with compatibility between the needle and syringe provided.Diagnosis for use: covid-19 vaccination.Fda safety report id# (b)(4).

• Brand Name: DROPSAFE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.
• MDR Report Key: 11398289
• MDR Text Key: 234457670
• Report Number: MW5099699
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/25/2021

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
• Device Operator: Health Professional
• Device Lot Number: 0323250006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1