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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. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number B55005
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Initial reporter full phone number: (b)(6).
 
Event Description
The complaint/event occurred on an unspecified date and involved a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext that was reportedly leaking.There was no report of human harm as a result of this complaint/event.
 
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Brand Name
14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK
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 Key19138744
MDR Text Key341466413
Report Number9617594-2024-00445
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCA
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 Nurse
Type of Report Initial
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB55005
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2024
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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