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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. CHEMOCLAVE VENTED VIAL SPIKE, 13MM SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE VENTED VIAL SPIKE, 13MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number CH-72
Device Problems Fluid Leak (1250); Component Missing (2306)
Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.
 
Event Description
The event involved a chemoclave® vented vial spike, 13mm that was missing the filter on the device, and this defect was noted once the bottle is pierced to withdraw the dose. It was reported that the missing filter generated a flow at the filter location which lead to an unprotected chemotherapy exposure and also the loss of the content of the bottle during drug preparation. There was no patient involvement or delay in therapy as the issue was detected prior to patient use. The device was replaced with no further problem encountered. Although unspecified negative clinical consequences on the operator were reported, there was no report of harm or adverse event.
 
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Brand NameCHEMOCLAVE VENTED VIAL SPIKE, 13MM
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
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key11665007
MDR Text Key250424009
Report Number9617594-2021-00105
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCH-72
Device Lot Number4998195
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 Received06/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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