Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ACCESS; STOPCOCK, I.V. SET
  • 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
 

BAXTER HEALTHCARE CORPORATION ACCESS; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C6255
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that a nurse observed air bubbles in the tubing of a clearlink continu-flo solution set during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4).Additional information: the device was not returned; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCESS
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
600 mts oeste de entrada
cartago
CS 
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
600 mts oeste de entrada
cartago
CS  
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4685383
MDR Text Key5713436
Report Number1416980-2015-16389
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2C6255
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-