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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. 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/; STOPCOCK, I.V. SET Back to Search Results
Catalog Number B30183
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2023
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.
 
Event Description
The event involved a 32" (81 cm) appx 6.3 ml, 15 drop admin set w/0.2 micron filter, rotating luer w/filter cap, bag hanger, where it was reported that there was air in line, and the medication involved is taxol 182ml/hr.There was unknown patient involvement and unknown adverse reaction or need for medical intervention.
 
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Brand Name
32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/
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
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key17646025
MDR Text Key322219675
Report Number9617594-2023-00609
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00887709055445
UDI-Public(01)00887709055445(17)271201(10)13490373
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,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB30183
Device Lot Number13490373
Date Manufacturer Received08/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PLUM 360 (V 15.X), ICU MEDICAL; TAXOL, UNK MFR
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