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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL ICU MEDICAL CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM

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ICU MEDICAL ICU MEDICAL CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM Back to Search Results
Model Number CL-13
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2019
Event Type  Injury  
Event Description
Icu medical cl-13 chemolock bag spike with additive port malfunction. Fda safety report id # (b)(4).
 
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Brand NameICU MEDICAL CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL
san clemente CA 92673
MDR Report Key9426218
MDR Text Key169857657
Report NumberMW5091495
Device Sequence Number1
Product Code ONB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCL-13
Device Lot Number3601318
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/05/2019 Patient Sequence Number: 1
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