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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMARTSITE EXTENSION SET - NEEDLE-FREE VALVE

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SMARTSITE EXTENSION SET - NEEDLE-FREE VALVE Back to Search Results
Model Number REF # 22003E-07
Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2016
Event Type  Malfunction  
Event Description

After starting an iv attached extension set to hub and attempted to draw blood, unable to do so. Removed extension set and blood flowed freely, new extension set attached and i was able to draw blood for lab work without difficulty. Blood did not flow through the extension set.

 
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Brand NameSMARTSITE EXTENSION SET - NEEDLE-FREE VALVE
Type of DeviceSMARTSITE
MDR Report Key6202197
MDR Text Key63276149
Report NumberMW5066894
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)
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 12/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREF # 22003E-07
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

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