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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE ACCESS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Break (1069); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that a buretrol set broke along the sides and split open.It was reported that the patient line had been changed.There was no patient injury or medical intervention associated with this event.Additional information was requested and is not available.
 
Manufacturer Narrative
(b)(4).(b)(6).The device has been received by baxter and is currently awaiting evaluation.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.
 
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Brand Name
ACCESS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE
Manufacturer (Section G)
BAXTER HEALTHCARE
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3759300
MDR Text Key4466011
Report Number1416980-2014-12597
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2014
Initial Date FDA Received04/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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