MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	24331
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
I was sticking a patient with a vanishpoint 21 g.I clicked the button and blood shot out the side all over my hand that was gloved.I had to change gloves before doing anything else with patient.Manufacturer response for tubes, vials, systems, serum separators, blood collection, vanishpoint (per site reporter).Mfr sent clinical rep along with territory manager, will be sending trainers next week.

• Brand Name: VANISHPOINT®
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8635470
• Report Number: 8635470
• Device Sequence Number: 1858365
• Product Code: JKA
• UDI-Device Identifier: 00613703243300
• UDI-Public: (01)00613703243300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/22/2019
• Report Date (Section F): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 24331
• Device Catalogue Number: 24331
• Device Lot Number: U19202
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/22/2019