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U.S. Department of Health and Human Services

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

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RETRACTABLE TECHNOLOGIES INC. VANISHPOINT INSULIN SYRINGE Back to Search Results
Model Number 15221
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2015
Event Type  malfunction  
Event Description
After insulin injection, #30g x. 5", 0. 5 ml. Insulin syringe needle did not retract and was recapped. This also occurred with a second syringe from the same lot on (b)(6). No injury to patient or staff.
 
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Brand NameVANISHPOINT
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
RETRACTABLE TECHNOLOGIES INC.
511 lobo lane
little elm TX 75068 0009
MDR Report Key5641189
MDR Text Key44842294
Report NumberMW5062153
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2019
Device Model Number15221
Device Lot NumberM 141101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2015
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

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