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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. 5" (13 CM) SMALLBORE EXT SET W/MICROCLAVE T-CONNECTOR, CLAMP, LUER SLIP; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) SMALLBORE EXT SET W/MICROCLAVE T-CONNECTOR, CLAMP, LUER SLIP; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-CT1100
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The lot number is unknown, therefore, a device history review cannot be performed.
 
Event Description
The event involved a smallbore ext set w/microclave® t-connector, clamp, luer that the customer stated, "when using t-c, blood spurts from the blue end." no other information was provided.
 
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Brand Name
5" (13 CM) SMALLBORE EXT SET W/MICROCLAVE T-CONNECTOR, CLAMP, LUER SLIP
Type of Device
STOPCOCK, I.V. SET
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 Key10605825
MDR Text Key214151311
Report Number9617594-2020-00425
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-CT1100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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