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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
Catalog Number D1000
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device was discarded and is not available for evaluation. Without the returned device a probable cause is unable to be determine.
 
Event Description
The events occurred involved the tego connector that the customer reported the product cracked and leaked blood. The event happened on day two of their dialysis for the week. There was patient involvement and no human harm.
 
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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 Key10983304
MDR Text Key220684065
Report Number9617594-2020-00531
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD1000
Device Lot Number4362825
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2019
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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