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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON MFG LIFEGUARD SAFETY HUBER NEEDLE

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VYGON MFG LIFEGUARD SAFETY HUBER NEEDLE Back to Search Results
Catalog Number CLGY-2034
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
Please see mdr 2245270-2017-00030 for data for an additional occurence of this malfunction with this customer. The malfunctioning device was returned to vygon for evaluation as part of the complaint investigation. The results of this investigation are still pending and will be communicated to fda within thirty days of its conclusion via follow-up mdr.
 
Event Description
Safety malfunction: the needle protrudes through the safety cap which is a potential hazard to the nurse handling the needle for risk of being stuck by a contaminated needle.
 
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Brand NameLIFEGUARD
Type of DeviceSAFETY HUBER NEEDLE
Manufacturer (Section D)
VYGON MFG
87 venture drive
dover NH 03820
Manufacturer (Section G)
VYGON MFG
87 venture drive
dover NH 03820
Manufacturer Contact
jillian mikovich
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key6661752
MDR Text Key78238458
Report Number2245270-2017-00031
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013871
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCLGY-2034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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