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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 Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 01/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to return for evaluation. The device has not been received.
 
Event Description
The event involved a tego® connector where the patient¿s line became disconnected from the tego during dialysis, resulting in blood loss and required an emergency visit. On (b)(6) 2020, around 1630hr the patient called out reporting they were not feeling well. It was discovered the venous line had separated from the tego of the cvc (central venous catheter) and the tego was still attached to the cvc. The customer reported that 700ml of normal saline was infused and at 1650hr, the patient was transported to (b)(6) ((b)(6) hospital) by ems with a stable blood pressure. The tego had been used on the patient since (b)(6) 2019, 5 days. There was no kink or defect noted on the device. No additional information available.
 
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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
christopher zanoni
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key9648810
MDR Text Key187698322
Report Number9617594-2020-00029
Device Sequence Number1
Product Code FPA
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD1000
Device Lot Number4134681
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2019
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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