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

Lot Number A170405

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

I went to administer a b12 injection to the pt and the needle would not pierce her skin.I tried to push harder to get the needle to pierce through; however, it did not go through to first layer of skin.I then disposed of the medication and disposed of the needle.I had to draw up another b12 with another needle from the same lot number, and that needle was able to go through her skin to the muscle easily.

• Brand Name: VANISHPOINT SYRINGE
• Type of Device: VANISHPOINT SYRINGE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.
• MDR Report Key: 7024671
• MDR Text Key: 91945544
• Report Number: MW5073257
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: A170405
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1