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U.S. Department of Health and Human Services

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

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ICU MEDICAL, INC. SPINNING SPIROS CAP CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Lot Number 5355619
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 09/11/2021
Event Type  malfunction  
Event Description
Patient's spiros cap became disconnected from the primary tubing. Chemo was not running in it at the time. The patient was dripping blood on the floor out of the spiros cap.
 
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Brand NameSPINNING SPIROS CAP
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 Key12553718
MDR Text Key274054180
Report Number12553718
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 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5355619
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2021
Event Location Hospital
Date Report to Manufacturer09/30/2021
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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