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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 14687-15
Device Problems Break (1069); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
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 primary plum set, clave secondary port, clave y-site, secure lock, 103 inch where it was reported there was occlusion at cassette, the clave on cassette was snapped off.There was unknown patient involvement, and unknown patient harm.
 
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Brand Name
PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18614893
MDR Text Key334844809
Report Number9615050-2024-00083
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10887787005650
UDI-Public(01)10887787005650(17)260401(10)13591617
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2024
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
Device Operator Health Professional
Device Catalogue Number14687-15
Device Lot Number13591617
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2024
Initial Date FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2023
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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