MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT®; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 24131

Device Problems Retraction Problem (1536); Unintended Movement (3026)

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

I was using the needle vanish point 21g and as i was trying to retract the needle by pushing the button on the side it took more force to retract the needle it caused it to flip over while in the pts arm causing pt pain.I apologized to her and held pressure a few mins and checked for bruising.It did appear bruising will occur.I asked pt repeatedly if she was ok or if she needed anything.She stated she was ok.Manufacturer response for vanishpoint, vanishpoint (per site reporter).Mfr sent clinical rep along with territory manager, will be sending trainers next week.

• Brand Name: VANISHPOINT®
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; 511 lobo ln; little elm TX 75068
• MDR Report Key: 8635460
• MDR Text Key: 145924618
• Report Number: 8635460
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 24131
• Device Catalogue Number: 24131
• Device Lot Number: 97660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1