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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 7N8301
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Event Description
Patient¿s mother pressed call bell stating, "the needle was coming out of his arm. " upon rn assessment, noted that iv extension tubing appeared to have disconnected from the hub of the needle and was leaking. Upon further assessment and attempt at flushing extension tubing once securement between the two pieces was established, rn noted a crack/hole in the extension tubing and saline was leaking out of the side of the extension tubing. Extension tubing changed and iv access remained intact. No harm met patient. Extension tubing and dressing only had to be changed. Damaged tubing saved and reported to unit manager.
 
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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 Key12466930
MDR Text Key271261452
Report Number12466930
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
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8301
Device Catalogue Number7N8301
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2021
Event Location Hospital
Date Report to Manufacturer09/14/2021
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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