MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE, 1ML U-100 INSULIN SYRINGE; SYRINGE PISTON

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)

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

Event Date 08/02/2018

Event Type  malfunction  

Event Description

Lantus insulin dose 30 units - syringe sent from pharmacy to floor contained approximately 25 units.Upon examination of the product, it appeared that some of the insulin was pushed out of the syringe (the plunger pushed up during delivery) because there was insulin present in the cap of the syringe.Upon investigation, multiple issues have been noted with these syringes, to include syringes will not draw liquid, plunger seems to draw a vacuum.One syringe did not have a rubber ring on the plunger.The plunger moves very easily and can become dislodged from the syringe resulting in a discarded syringe and wasted dosage.No reported pt harm from these events.

• Brand Name: VANISHPOINT SYRINGE, 1ML U-100 INSULIN SYRINGE
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 7768901
• MDR Text Key: 116789741
• Report Number: MW5078980
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 84 YR