MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHING POINT; TUBERCULIN SYRINGE, 1 ML, 25G, 5/8" NEEDLE

Catalog Number 61370310150

Device Problems Fluid/Blood Leak (1250); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem Underdose (2542)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

When trying to administer 1 cc solution of 0.35 cc methylprednisolone 40 mg/ml with 0.65 cc lidocaine 2% using a vanishing point tuberculin syringe, there was plunger resistance.Only 0.5 cc of solution was administered when the needle retracted and the rest of the medication spilled.

• Brand Name: VANISHING POINT
• Type of Device: TUBERCULIN SYRINGE, 1 ML, 25G, 5/8" NEEDLE
• Manufacturer (Section D): RETRACTABLE TECHNOLOGIES, INC.; little elm TX 75068
• MDR Report Key: 4834768
• MDR Text Key: 22066217
• Report Number: MW5042998
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 61370310150
• Device Lot Number: G131004
• Other Device ID Number: 6 13703 10150 1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: NEURONTIN 300 MG PO AM; CELEBREX 200 MG PO QD; NEURONTIN 600 MG PO HS
• Patient Age: 57 YR
• Patient Weight: 94