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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. CONECTOR TEGO SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CONECTOR TEGO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number LAT-D1000
Device Problem Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available for evaluation. Without the returned device a probable cause is unable to be established.
 
Event Description
The event involved a connector tego that the customer reported twenty minutes after initiating personal care therapy, 20 ml of blood leakage was noted thought the tego connector. The customer stated it was rolled, so the defective device was changed for another of the same reference number and the therapy was continued without complications. There was patient involvement, however, no report of adverse event.
 
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Brand NameCONECTOR TEGO
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 Key11065158
MDR Text Key223602734
Report Number9617594-2020-00544
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberLAT-D1000
Device Lot Number4756482
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 Received12/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2020
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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