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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER INTERNATIONAL INC. ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7N8399
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 09/14/2021
Event Type  malfunction  
Event Description
There was no device in three individual packages of baxter one-link needle-free iv connector. The packaging is completely sealed with only air and no actual device. Lot ur21c24033.
 
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Brand NameONE-LINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key12525352
MDR Text Key273112772
Report Number12525352
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8399
Device Catalogue Number7N8399
Device Lot NumberUR21C24033
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/17/2021
Event Location Hospital
Date Report to Manufacturer09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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