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

Model Number	3ML 25GX1"
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
We have noticed changes in the quality of vanishpoint 3 ml 25g x 1" syringes over the past year.In three of our offices, nurses with 20-35+ years of experience have noted the pre-attached needle bends, breaks off at the hub, or seems dull and takes extra pressure to puncture the skin.One needle had no level.We notified retractable technologies, inc., and sent syringes from lot number a161204 (exp 11/28/2021) for testing.We received a letter from retractable technologies, and e-mail from one of their reps, advising that the syringes were fine but that our nurses may need more training.We feel that has been a change in the quality of the product, and that our very experienced immunization nurses do not need further training on using the syringes.Our medical director asked that we submit this in case other agencies have noticed quality issues with vanishpoint syringes.Fda safety report id # (b)(4).

• Brand Name: VANISHPOINT SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC. ; little elm TX 75068
• MDR Report Key: 8883422
• Report Number: MW5088937
• Device Sequence Number: 233555
• Product Code: MEG
• UDI-Device Identifier: 00613703103901
• UDI-Public: (01)00613703103901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: 3ML 25GX1"
• Device Catalogue Number: 10391
• Device Lot Number: A161204
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1