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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number D1000
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
Event Type  malfunction  
Event Description
The event involved a tego¿ connector which was reported to have leaked an unspecified amount of blood from the central venous catheter, just after the plug. No medication was used with this device. The event occurred during patient use; there was delay in therapy, but no harm was reported as a consequence of this event.
 
Manufacturer Narrative
The device was not returned for evaluation. Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
 
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Brand NameTEGO® CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX 22790
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key14014755
MDR Text Key291404581
Report Number9617594-2022-00074
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD1000
Device Catalogue NumberD1000
Device Lot Number5189867
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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