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

Lot Number M170405

Device Problems Fluid/Blood Leak (1250); Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2018

Event Type  malfunction  

Event Description

While administering dose of insulin to patient some insulin went behind plunger and was not administered to patient and some squirted onto rn gloves.Unsafe because uncertain how much insulin was administered to patient.The needle did retract.Also a picture of my gloved hand and the syringe immediately after the event occurred showing some insulin had seeped out somehow.Doctor was notified.

• 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: 7365289
• MDR Text Key: 103336877
• Report Number: 7365289
• 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: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: M170405
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR