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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C5645
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an extension set had an issue with the retractable collar. The reporter stated that the retractable collar is stuck. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
(b)(4). A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not returned; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameEXTENSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer (Section G)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5667523
MDR Text Key45573210
Report Number1416980-2016-09404
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C5645
Device Lot NumberR16C03125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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