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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC 6" SMALLBORE TRIFUSE EXT SET; STOPCOCK, I.V. SET
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ICU MEDICAL, INC 6" SMALLBORE TRIFUSE EXT SET; STOPCOCK, I.V. SET Back to Search Results
Model Number MC33194
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 04/10/2022
Event Type  malfunction  
Event Description
Patient found by this rn to be using his left hand, which is in a soft wrist restraint, pulling his ekg leads off, hitting the buttons on the bed and inadvertently raising the head of bed and feed up and down, and playing with the snap closure of the restraint.Bedside rn came to his bedside and noticed the iv trifuse tubing laying across the patient had snapped off of the connection to his left arm picc.The attachment end of the trifuse was still attached to one of the picc lumens.The patient's precedex gtt had been infusing through this line.Snapped line was detached from patient, a new bag of precedex was ordered since the line had been open for a undetermined amount of time.Tubing sent to bme and biomedical noted separation of male lurer extension form the trifuse apex.
 
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Brand Name
6" SMALLBORE TRIFUSE EXT SET
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC
951 calle amancer
san clemente CA 92673
MDR Report Key14159693
MDR Text Key289611122
Report Number14159693
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 Biomedical Engineer
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMC33194
Device Catalogue NumberMC33194
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2022
Event Location Hospital
Date Report to Manufacturer04/20/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age3650 DA
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