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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE; SYRINGE, ANTISTICK
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RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE; SYRINGE, ANTISTICK Back to Search Results
Lot Number G210955
Device Problems Retraction Problem (1536); Failure to Deliver (2338); Activation, Positioning or Separation Problem (2906)
Patient Problem Pain (1994)
Event Date 05/09/2022
Event Type  malfunction  
Event Description
"plunger would not inject any medication or move at all when trying to administer immunization during im injection.Patient "poked" again with a new needle, syringe, and immunization after first one didn't work.(medication was only injected once) i used the government provided vanishing syringe and needle.Multiple instances of numerous problems with the vanishing needle not retracting while in the patient¿s arm without having to apply an unreasonable amount of pressure to the syringe, causing patients more pain.In this case, i have to remove the needle from the patients arm, hold the needle away, and press down firmly on the plunger to get the needle to retract.I don¿t feel that this is safe for the nurses or the patients." no sample available.
 
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Brand Name
VANISHPOINT SYRINGE
Type of Device
SYRINGE, ANTISTICK
Manufacturer (Section D)
RETRACTABLE TECHNOLOGIES, INC.
511 lobo ln
little elm TX 75068
MDR Report Key14711670
MDR Text Key294129714
Report Number14711670
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberG210955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2022
Event Location Other
Date Report to Manufacturer06/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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