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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK PACLITAXEL SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK PACLITAXEL SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8858
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a clearlink, paclitaxel set leaked somewhere between the pump segment and filter. The issue was identified during an unspecified process step, before leaving the intravenous (iv) room. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Device manufacturer address 1: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK PACLITAXEL SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key15251342
MDR Text Key302407796
Report Number1416980-2022-04328
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412565774
UDI-Public(01)00085412565774
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2R8858
Device Lot NumberR22C26116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2022
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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