MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC VANISHPOINT SYRINGE; SYRINGE, ANTISTICK

Model Number 3ML, 23G, 1 INCH

Device Problems Retraction Problem (1536); Dull, Blunt (2407)

Patient Problem Discomfort (2330)

Event Date 10/18/2019

Event Type  malfunction  

Event Description

Patient went to the fmd office for her scheduled depo­-provera shot.Syringe/needle setup was used to draw up/administer the medication.While attempting to inject the medication, it was noted that the needle was dull and very difficult to administer.The patient complained of discomfort when needle was removed and it was difficult to retract the needle.

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC; 511 lobo ln; little elm TX 75068
• MDR Report Key: 9266317
• MDR Text Key: 165094244
• Report Number: MW5090828
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ML, 23G, 1 INCH
• Device Lot Number: A884A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 36 YR