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

MAUDE Adverse Event Report: CAREFUSION TUBING SET, ADMINISTRATION, INTRAVASCULAR

  • 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
 

CAREFUSION TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 10015862
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problems Burning Sensation (2146); Chemical Exposure (2570)
Event Type  No Answer Provided  
Event Description
Safety concern; chemo spill; summary: during the infusion of a 1000 ml bag of etoposide, doxorubicin, vincristine (vesicants), the spike came out of the bag and spilled all over the nurse. Background: the bag was spiked using a short primary tubing and connected to an alaris pump. Patient ambulated to the bathroom, as rn waited for the patient, rn noticed that there was a bubble in the iv tubing and lightly flicked the tubing to get rid of the bubble; instead the iv tubing detached from the bag and as a result there was a chemo spill. Result: the nurse felt as if her skin was burning, similar to a sunburn. She did not see a physician, it did not blister. Patient was not harmed or spilled on. Spilled chemo bag was disposed appropriately and new chemo bag was given/hung. Product information: the model/ref number of the tubing is 10015862 (carefusion). The model/ref number of the normal saline bag is e8000, ndc (b)(4) (bbraun). Assessment: due to the stiffness of the port of the bag and the unsecured nature of the connection between the port of the iv tubing, our institution will switch products to prevent other chemo spills. Relevant materials provided: image. (b)(6). (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
MDR Report Key8339474
MDR Text Key137132751
Report NumberMW5084054
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 02/13/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number10015862
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

-
-