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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. 168 CM (66") APPX 2.4 ML, PUR YELLOW SMALLBORE EXT SET, 3-PORT NANOCLAVE¿ MANIFO; STOPCOCK, I.V. SET
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 168 CM (66") APPX 2.4 ML, PUR YELLOW SMALLBORE EXT SET, 3-PORT NANOCLAVE¿ MANIFO; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 011-AM3106
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
The event involved a 168 cm (66") appx 2.4 ml, pur yellow smallbore ext set, 3-port nanoclave¿ manifold w/check valve, nanoclave¿, nanoclave¿ 4-way stop cock (red ring), rotating luer where the customer reported that at 7:30 am, a leak was noticed at the level of the screw thread between the yellow icu tubing and the start of the manifold.A parenteral nutrition was administered.Date of installation: on (b)(6) 2024 and the leak was noticed the next morning, on (b)(6) 2024.The nurse declared the event on march 20, 2024.Date of withdrawal: on (b)(6) 2024.Clinical consequences: change of the device and perfusion.The event was reported to the neonatal technical nurse.There was patient involvement, no adverse event/human harm, and no need of medical intervention.The event happened when the device was put in place.The treatment was not fully administered.No loss of blood.The medication did not come in contact with the patient and healthcare provider.
 
Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
 
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Brand Name
168 CM (66") APPX 2.4 ML, PUR YELLOW SMALLBORE EXT SET, 3-PORT NANOCLAVE¿ MANIFO
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 Key19133214
MDR Text Key340480608
Report Number9617594-2024-00443
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 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 Number011-AM3106
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
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
PARENTERAL NUTRITION, MFR UNK
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