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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL, INC. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number D1000
Device Problems Flushing Problem (1252); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 06/10/2022
Event Type  malfunction  
Event Description
Recent issues with tego connector not flushing.Unable to aspirate or flush arterial lumen when disconnecting patient from hd treatment and had to change tego.Patient's hd completed with treatment and i was trying to flush arterial line after disconnecting arterial line.Arterial lumen was resistant and i wasn't able to aspirate or flush the line.A teammate disconnected tego and flushed arterial lumen, which was patent with no resistance.Tego was changed and able to aspirate and flush.Tego malfunctioned and could have made the patient more susceptible to infection.Continue to monitor access.There was no detectable harm in this event.This is a recurring issue.Unable to determine the specific lot # that was involved in this event.
 
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Brand Name
TEGO CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key14929251
MDR Text Key295344269
Report Number14929251
Device Sequence Number1
Product Code FPA
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 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberD1000
Device Catalogue NumberD1000
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/06/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age3285 DA
Patient SexFemale
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