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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8300
Device Problem Reflux within Device (1522)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing facility - this device was manufactured at one of the two following manufacturing sites: baxter healthcare (b)(4). should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was backflow in an unspecified quantity of one-link non-dehp microbore catheter extension sets which "allows more liquid to reflux back into the system".This issue was identified before use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; 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 Name
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9309742
MDR Text Key166837145
Report Number1416980-2019-06272
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8300
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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