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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. 79" (201 CM) APPX 9.7 ML, 60 DROP ADMIN SET W/15 MICRON FILTER, CLAVE¿, EASYDROP; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 79" (201 CM) APPX 9.7 ML, 60 DROP ADMIN SET W/15 MICRON FILTER, CLAVE¿, EASYDROP; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 126420460
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
 
Event Description
The event involved a 79" (201 cm) appx 9.7 ml, 60 drop admin set w/15 micron filter, clave, easydrop flow controller, rotating luer w/filter cap, where it was reported there were air in line issues.There was no report of patient harm or patient involvement.No additional information available.
 
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Brand Name
79" (201 CM) APPX 9.7 ML, 60 DROP ADMIN SET W/15 MICRON FILTER, CLAVE¿, EASYDROP
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 Key15891045
MDR Text Key307778364
Report Number9617594-2022-00310
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number126420460
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2022
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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