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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 7N8301
Device Problems Fluid Leak (1250); Improper Flow or Infusion (2954); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). This device was manufactured at one of the two following manufacturing sites: (b)(4). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that multiple air bubbles and leakage of blood was observed while using a one-link non-dehp standard bore catheter extension set and a non-baxter iv (intravenous catheter). This was observed during flash back of blood when a 22-guage saline lock was initiated. Saline lock was flushed well but continued to leak air and drip blood from the connection site. A new connection was put in place but continued to leak blood. As a result, the saline lock and needle hub were removed and the patient¿s iv was replaced to continue with the therapy. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
see h10
see h10
see h10
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11032486
MDR Text Key222713913
Report Number1416980-2020-07895
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8301
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
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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