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U.S. Department of Health and Human Services

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

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ICU MEDICAL, INC. CHEMOLOCK CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Lot Number 5686058
Device Problems Fluid Leak (1250); Defective Component (2292)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
Chemolock vial spike, 20mm lot 5686058 was being used in a paclitaxel vial. After technician pulled about 10ml of the drug it would only pull air and when pushing the air back into the vial drug began to leak around the spike.
 
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Brand NameCHEMOLOCK
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 Key13948743
MDR Text Key288180601
Report Number13948743
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 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5686058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2022
Event Location Hospital
Date Report to Manufacturer03/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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