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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8403
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2022
Event Type  malfunction  
Manufacturer Narrative
The user facility submitted medwatch (b)(4) for this event.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system non-dehp solution set leaked from the distal y-site connection.The issue was identified during patient infusion with an unspecified chemotherapy drug.A drop of the chemotherapy drug got on patient's hand; however, the patient was instructed to wash their hands thoroughly.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK LUER ACTIVATED VALVE
Type of Device
SET, 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 91000
DR   91000
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key15846708
MDR Text Key307279402
Report Number1416980-2022-06408
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412656649
UDI-Public(01)00085412656649
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2R8403
Device Lot NumberDR22E23024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received12/14/2022
Supplement Dates FDA Received12/21/2022
Date Device Manufactured05/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNSPECIFIED CHEMOTHERAPY
Patient Age60 YR
Patient SexFemale
Patient Weight78 KG
Patient RaceWhite
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