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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET Back to Search Results
Model Number MC9079
Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
Filter outflow tubing didn't get attached to the outflow port of the filter during inspection the outflow tubing became separated from the filter entirely.Icu medical filter (ref mc9079) discovered during fluid priming to have an additional piece of plastic that leaked fluid out immediately.Item was replaced, and fluid priming continued without incident.Unfortunately the original package was discarded so no lot number is available.Manufacturer contacted and defective product mailed to them.There was no patient involved.
 
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Brand Name
17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key11435060
MDR Text Key238338341
Report Number11435060
Device Sequence Number1
Product Code FMG
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 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMC9079
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2021
Event Location Hospital
Date Report to Manufacturer03/08/2021
Type of Device Usage Unknown
Patient Sequence Number1
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