• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device is available for evaluation. It has not been received.
 
Event Description
The event involved a tego connector. The customer stated that the tego had, ¿degeneration of seal on bung, breakdown of outer plastic as well as the inner mechanism, unable to flush once broken. ¿ there was blood loss of one whole circuit, roughly 200 mls. The patient¿s hemoglobin level was 101. The medical interventions required was the, ¿wash back of the machine, new machine was set up, loss of blood. ¿ the tego was in use for less than 10 minutes. The setup was described as the tego was cleaned, lock off of line drew back through the bung, line was flushed, and then attached to hemodialysis machine. No other information was provided. This report is for the second of two events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10940971
MDR Text Key219521666
Report Number9617594-2020-00521
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD1000
Device Lot Number4775688
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 Received02/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-