• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. 30" APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMO LOCK DRIP CHAMBER, SPIRO CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ICU MEDICAL, INC. 30" APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMO LOCK DRIP CHAMBER, SPIRO CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Lot Number 5579987
Device Problems Fluid Leak (1250); Connection Problem (2900); Separation Problem (4043)
Patient Problem Insufficient Information (4580)
Event Date 11/16/2021
Event Type  Injury  
Event Description
Nurse was hanging chemo (ifosfamide plus mesna), and the spike adaptor came out of the ns bag containing the chemo. The chemo spilled out of the bag onto the floor and onto the nurses chemo gown; 50 - 60 mls spilled. The spilled chemo was cleaned up per protocol using the chemo spill kit. A new bag of med was made. Nothing got onto the patient. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name30" APPX 3.3ML, 20 DROP ADMIN SET WITH INTEGRATED CHEMO LOCK DRIP CHAMBER, SPIRO
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL, INC.
MDR Report Key12868534
MDR Text Key281271552
Report NumberMW5105534
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 Risk Manager
Type of Report Initial
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number5579987
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 11/23/2021 Patient Sequence Number: 1
Treatment
IFOSFAMIDE; MESNA
-
-