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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 IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8331K
Device Problems Fluid Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a one-link non-dehp 3 lead microbore catheter extension set leaked. It was further reported that during priming the line with saline solution, a split was observed in the triple lumen set resulting in a leak. There was no patient involvement. No additional information is available.
 
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Brand NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina, san cristobal
DR
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12475060
MDR Text Key271498342
Report Number1416980-2021-05727
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
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 Other
Device Catalogue Number7N8331K
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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