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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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ICU MEDICAL, INC. SPINNING SPIROS, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Catalog Number CH2000SC-10
Device Problems Fluid Leak (1250); Physical Resistance/Sticking (4012)
Patient Problem Chemical Exposure (2570)
Event Date 02/03/2021
Event Type  malfunction  
Event Description
Patient was receiving vidaza injection with closed-system transfer device attached to the end of the syringe. Nurse met resistance with vidaza and while attempting to push the drug, vidaza sprayed out of the closed-system transfer device spraying onto nurse and patient.
 
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Brand NameSPINNING SPIROS, CLOSED MALE LUER
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key11313183
MDR Text Key231370472
Report Number11313183
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCH2000SC-10
Device Lot Number5021931
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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