MAUDE Adverse Event Report: VYGON INC. VYGON 10 # LIFEGUARD SAFETY INFUSION SET WITH 20 GAUAGE X 0.75" HUBER NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CLG-2034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When removing needle from port, the safety retraction piece on huber needle broke off.Near miss for needle stick.Fda safety report id # (b)(4).

• Brand Name: VYGON 10 # LIFEGUARD SAFETY INFUSION SET WITH 20 GAUAGE X 0.75" HUBER NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): VYGON INC.; lansdale PA 19446
• MDR Report Key: 9437683
• Report Number: MW5091519
• Device Sequence Number: 16912220
• Product Code: FPA
• UDI-Device Identifier: 08498840006283
• UDI-Public: (01)08498840006283(17)220531(10)
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CLG-2034
• Device Catalogue Number: CLG-2034
• Device Lot Number: 1905044D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1