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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. UNSPECIFIED TRIFUSE DEVICE; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED TRIFUSE DEVICE; STOPCOCK, I.V. SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
The event occurred on an approximate date of (b)(6) 2023 involving an unspecified trifuse device (transparent/non-transparent) where it was reported that the clave detached from tubing.There were two clave devices that have different lot numbers or list numbers because of the difference in the claves.They are not the same as one device has blue claves and the other device has microclaves that are blue/clear.There was unknown patient involvement and unknown patient harm.
 
Manufacturer Narrative
E1 - initial reporter phone has an ext: (b)(6).The device is available to be returned for evaluation; however, it has not yet been received.
 
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Brand Name
UNSPECIFIED TRIFUSE DEVICE
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 Key18959085
MDR Text Key339138699
Report Number9617594-2024-00321
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00(01)(17)(10)
UDI-Public(01)(17)(10)
Combination Product (y/n)N
Reporter Country CodeUK
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 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2023
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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