MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL, INC. SOL-M LUER LOCK SYRINGE WITH EXCHANGEABLE NEEDLE TRAY; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 1832110T

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Luer lock syringe with exchangable needle tray- needles are loose and falling off before use in the convenience tray.Up to 40% of needles fall off in a tray of 50 syringes.This creates a patient safety concern around keeping critical sites sterile.Fda safety report id# (b)(4).

• Brand Name: SOL-M LUER LOCK SYRINGE WITH EXCHANGEABLE NEEDLE TRAY
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL, INC.
• MDR Report Key: 10514328
• MDR Text Key: 206556813
• Report Number: MW5096521
• Device Sequence Number: 1
• Product Code: FMI
• 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: 09/08/2020

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 Expiration Date: 08/19/2023
• Device Model Number: 1832110T
• Device Lot Number: 18062527
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2020
• 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