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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. CHECK VALVE WITH MALE/FEMALE LUER LOCK; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHECK VALVE WITH MALE/FEMALE LUER LOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-CS25
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation.Photos were provided by the customer.Investigation is pending.Initial reporter address: (b)(6).
 
Event Description
The event involved a check valve with male/female luer lock, where it was reported in the infusion line, blood returns through the non-return valve.The event occurred in the anesthesia operating room when the product was placed on the infusion line.The valve was changed.The customer stated there was non clinically significant blood loss.There was a delay in therapy due to the time to change valve and bandage.The therapy was completed.There was no drug administered, but contrast agent.The doctor had some blood on his hands.There was no medical intervention needed, just hand washing.The leak did not come into contact with the patient.The leak was cleaned up according to facility protocol with no specific kit.The patient¿s condition before, during and after the incident was under general anesthesia.The patient received the full intended dose after changing the consumable.There was patient involvement, however, no report of patient harm.
 
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Brand Name
CHECK VALVE WITH MALE/FEMALE LUER LOCK
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 Key19043314
MDR Text Key340108071
Report Number9617594-2024-00368
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00840619006075
UDI-Public(01)00840619006075(17)280801(10)13745518
Combination Product (y/n)N
Reporter Country CodeFR
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 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-CS25
Device Lot Number13745518
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CONTRAST, UNK MFR; UNSPECIFIED INFUSION LINE, UNK MFR
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