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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 Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.Additional contact: (b)(6).
 
Event Description
The incident involved a tego¿ connector.As per the report, the tego cap silicon was coming off of the tego cap.The tego cap had to be changed as a result of the incident.There was patient involvement and no report of patient harm.
 
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Brand Name
TEGO® CONNECTOR
Type of Device
SET, 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
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18111701
MDR Text Key328042735
Report Number9617594-2023-00970
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00840619026059
UDI-Public(01)00840619026059(17)280601(10)13683044
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD1000
Device Lot Number13683044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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