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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. CLAVE® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number C1000
Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)
Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in the event is expected to be returned to the manufacturer for further evaluation.
 
Event Description
It was reported that the device experienced a silicone sleeve stick down event causing a small leak during fluorouracil infusion therapy. The reporter stated, the pump was programmed to run at a rate of 2ml/hr. The incident was said to have been detected, approximately, one hour after initializing therapy. Although there was a short delay in there, there was no negative impacts to the patient. No additional information is known at this time.
 
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Brand NameCLAVE® CONNECTOR
Type of DeviceSET, 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
Manufacturer Contact
emily arnould
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key8486697
MDR Text Key141051597
Report Number9617594-2019-00106
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2019 Patient Sequence Number: 1
Treatment
SALINE; SPIROS; TAXOL
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