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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. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET Back to Search Results
Catalog Number MC330419
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2026
Type of Reportable Event Malfunction
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Brand Name
102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
Common Device Name
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 Key25854865
Report Number9617594-2026-00877
Device Sequence Number12063271
Product Code FMG
UDI-Device Identifier00887709087552
UDI-Public(01)00887709087552
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K964435
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/17/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberMC330419
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2026
Initial Report FDA Received Date07/17/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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