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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. SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number CH2000S-C
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
 
Event Description
The event occurred on an unspecified date and involved a spinning spiros® closed male luer, red cap where the spiros disconnected from back of the spiros where the luer lock is inserted on a trifuse set, with a fixed collar.There was unspecified blood loss reported, not enough to warrant a transfusion, but enough to be concerning, as the patient was a bone marrow transplant (bmt) patient with a low hemoglobin and heightened infection risk.There was also a spill of an unspecified hazardous drug, but it was reported to be a small amount since patient was on a continuous and slow hazardous drug infusion.There was patient involvement, adverse event and no patient harm.
 
Manufacturer Narrative
No product samples were returned for investigation.The device history review for lot number 4969219, was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Additional information can be found in section d10.
 
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Brand Name
SPINNING SPIROS CLOSED MALE LUER, RED CAP
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
MDR Report Key10862362
MDR Text Key219567124
Report Number9617594-2020-00500
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00840619026615
UDI-Public(01)00840619026615(17)250801(10)4969219
Combination Product (y/n)N
PMA/PMN Number
K082806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCH2000S-C
Device Lot Number4969219
Was Device Available for Evaluation? No
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNSPEC TRIFUSE SET, MFR ICU MEDICAL.
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