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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL NANOCLAVE STOPCOCK; 4-WAY STOCKCOCK
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ICU MEDICAL NANOCLAVE STOPCOCK; 4-WAY STOCKCOCK Back to Search Results
Model Number AC205
Device Problem Connection Problem (2900)
Patient Problem Chemical Exposure (2570)
Event Date 10/11/2017
Event Type  malfunction  
Manufacturer Narrative
A two year review of complaints database revealed no additional reports.
 
Event Description
Separation/leakage reported.Customer reports that the nanoclave just pops off when the spiros is removed.Report of chemo spillage on pharmacist's hand.Device was returned for evaluation.Visual inspection revealed that package contained the device with a broken port which had evidence of external force applied through the package.
 
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Brand Name
NANOCLAVE STOPCOCK
Type of Device
4-WAY STOCKCOCK
Manufacturer (Section D)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer (Section G)
ICU MEDICAL
4455 atherton drive
salt lake city UT 84117
Manufacturer Contact
holly imes
4455 atherton drive
salt lake city, UT 84117
8012641747
MDR Report Key7044792
MDR Text Key93216700
Report Number2025816-2017-00244
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00887709084438
UDI-Public887709084438
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2021
Device Model NumberAC205
Device Catalogue NumberAC205
Device Lot Number3372476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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