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

Lot Number M170405

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 02/10/2018

Event Type  malfunction  

Event Description

When i went to administer insulin into my patient's posterior arm i inserted the needle and then began to push plunger to administer, while needle was injected in patient's arm, insulin leaked out of sides and appeared to leak backward in syringe as in behind the plunger.It created an unsafe condition because i'm not certain how much insulin my patient actually received.On a separate note when drawing up insulin with same type of syringe about 2 weeks ago i noticed that insulin leaked onto the other side of plunger within syringe chamber as well, i simply replaced the entire syringe and redrew my dose for the patient.

• 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: 7276774
• MDR Text Key: 100278482
• Report Number: 7276774
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: M170405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR