• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE AUTOMATED RETRACTION TECHNOLOGY 1CC U-100 29G X 1/2" INSULIN SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE AUTOMATED RETRACTION TECHNOLOGY 1CC U-100 29G X 1/2" INSULIN SYRINGE Back to Search Results
Catalog Number 10211
Device Problem Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/08/2016
Event Type  malfunction  
Event Description
Nurse administered insulin medication via subcutaneous injection to patient using vanish point retractable insulin syringe. After administration of medication nurse heard click indicating needle retracted and verified the needle retraction. While gathering items used for medication pass, nurse felt a prick to the left index finger and noticed that needle had re-erected out of the syringe and the nurse had sustained a needle stick to finger.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVANISHPOINT SYRINGE AUTOMATED RETRACTION TECHNOLOGY
Type of Device1CC U-100 29G X 1/2" INSULIN SYRINGE
Manufacturer (Section D)
RETRACTABLE TECHNOLOGIES, INC.
little elm TX 75068
MDR Report Key5895853
MDR Text Key52847417
Report NumberMW5064238
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2017
Device Catalogue Number10211
Device Lot NumberF262A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-