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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. 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-C32029
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
The event involved a 22 cm (8.5") ext set w/0.2 micron filter, clamp, rotating luer where it was reported the fluid was hard to drip.There was no concomitant drug with no concomitant device involved.There was no bleedback, no chemo, no biohazard and unknown user facility medwatch.Device was not reprocessed resterilized.
 
Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
 
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Brand Name
22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER
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 Key18966478
MDR Text Key338452592
Report Number9617594-2024-00334
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,Company Representative
Reporter Occupation Other Health Care Professional
Report Date 03/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-C32029
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2024
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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