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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. SMALLBORE EXT SET W/REMV MICROCLAVE; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. SMALLBORE EXT SET W/REMV MICROCLAVE; STOPCOCK, I.V. SET Back to Search Results
Model Number MC33425
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 01/14/2022
Event Type  malfunction  
Event Description
Newly primed and hung iv filter tubing had tpn running through a patient¿s central line.Rn went to administer iv tylenol and noticed that the filter tubing was leaking.Rn followed the line from bag to patient and noticed a crack within the filter of the filter tubing, which contributed to the leak.The rn then had to re-prime new iv filter tubing and reconnect it to the patient.This incident caused the rn to have to ¿break¿ the line, meaning unexpectedly disconnect the tubing from the patient, which puts the patient at an increased risk for infection.
 
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Brand Name
SMALLBORE EXT SET W/REMV MICROCLAVE
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key13415376
MDR Text Key284811012
Report Number13415376
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 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC33425
Device Catalogue NumberMC33425
Device Lot Number5463469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/19/2022
Event Location Hospital
Date Report to Manufacturer02/01/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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