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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOLOCK - BAG SPIKE WITH ADDITIVE PORT (CL-13); CLOSED ANTINEOPLASTIC AND DRUG RECONSTITUTION AND TRANSFER SYSTEM
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ICU MEDICAL, INC. CHEMOLOCK - BAG SPIKE WITH ADDITIVE PORT (CL-13); CLOSED ANTINEOPLASTIC AND DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number CL-13
Device Problems Break (1069); Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
Patient Problems Chemical Exposure (2570); No Code Available (3191)
Event Date 08/29/2019
Event Type  Injury  
Event Description
Cl-13 chemolock bag spike with additive port from icu medical, inc.Mfr defects were syringe adapter flange on the bag spike was turned in and not turned out to accept syringe adapter from icu medical to maintain a closed system while compounding hazardous drug, carfilzomib.Upon pharmacy tech attempting to connect the bag spike adaptor to the syringe adapter, the end of the entire syringe broke apart as it was unable to be, "clicked" together for a closed system.This resulted in a pt treatment delay, pharmacy staff exposure to hazardous drug, and loss of expenses.
 
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Brand Name
CHEMOLOCK - BAG SPIKE WITH ADDITIVE PORT (CL-13)
Type of Device
CLOSED ANTINEOPLASTIC AND DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL, INC.
MDR Report Key8982530
MDR Text Key158352221
Report NumberMW5089671
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2023
Device Model NumberCL-13
Device Lot Number3601318
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight62
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