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U.S. Department of Health and Human Services

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

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RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT; SYRINGE, ANTISTICK Back to Search Results
Model Number 1301
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 09/08/2015
Event Type  malfunction  
Event Description
After injecting the sterile diluent into the mmr power vial, the syringe spring came out and the syringe fell apart.
 
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Brand Name
VANISHPOINT
Type of Device
SYRINGE, ANTISTICK
Manufacturer (Section D)
RETRACTABLE TECHNOLOGIES, INC.
511 lobo lane
little elm TX 75068
MDR Report Key5140139
MDR Text Key27981783
Report Number5140139
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 09/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1301
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2015
Event Location Other
Date Report to Manufacturer09/30/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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