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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8480
Device Problems Backflow (1064); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6). Device manufacturer address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink, non-dehp solution set leaked. It was observed during patient use. The tubing was connected to a tpn (total parenteral nutrition) bag and was found to be wet right under the drip chamber. The drops were wiped off and within 5 minutes, the fluid had re-accumulated on the tubing. The fluid appeared to be leaking out from where the tubing connects to the drip chamber. New tubing was used to continue treatment. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13119905
MDR Text Key283115637
Report Number1416980-2021-07619
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2R8480
Device Lot NumberR21D07085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.; TPN BAG.
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