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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. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-H3393
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
The event involved a 28 cm (11") add-on set w/2 check valves, vented cap, non-dehp where the customer reported a defect on a tree, when the nurse started administering chemotherapy, she observed a "geyser" leak at the connection valve of the tubing to the tree.This valve disconnected from the tree.Furthermore, the liquid took on a slightly brown color, as if it had been dyed, and had taken on the color of the plastic where this valve is inserted.According to the photo, you can see the valve disconnected from the tree, and the brown splashes on the white plastic.One photo of the device schematic, with the customer circling and numbering 2 areas.The status of the product at the time of the event is when staring administering chemotherapy.There was unknown patient involvement, unknown adverse event/human harm.
 
Manufacturer Narrative
The device is not available for evaluation; however, a photo was received and the investigation is pending for completion.E1 - initial reporter phone is (b)(6).
 
Manufacturer Narrative
The complaint on the 011-h3393 could not be confirmed by investigation.A photo was returned showing the drawing of the configuration of the device and the areas where leakage was observed.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) could not be reviewed due to the unknown lot number.
 
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Brand Name
28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
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 Key18935193
MDR Text Key338987349
Report Number9617594-2024-00296
Device Sequence Number1
Product Code FMG
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 Pharmacist
Type of Report Initial
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-H3393
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2024
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
Treatment
CHEMOTHERAPY, MFR UNK; TUBING, MFR UNK
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