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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problems Backflow (1064); Crack (1135); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported backflow was observed in a one-link needle-free iv connector. While connected to a pediatric patient, there was blood reflux noted in the tubing "through the q-site" resulting in a possible external leak onto the "patient's bed". A crack was observed; however, it was not specified as to the location of the crack. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12478848
MDR Text Key271673473
Report Number1416980-2021-05762
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
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 10/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7N8399
Device Lot NumberUR21E05060
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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