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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK PACLITAXEL SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8858
Device Problems Use of Device Problem (1670); Component Missing (2306); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
Prior to beginning the sterile compounding of the antineoplastic agent paclitaxel, a baxter paclitaxel set was removed from its outer wrapper in order to attach it to an iv bag and to prime the set. It was noted that the set was missing the male luer connector at its distal end thus rendering the set unusable. No needle nor closed system transfer device could be attached, and the set will need to be discarded. The roller clamp was also missing. Fda safety report id #: (b)(4).
 
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Brand NameCLEARLINK PACLITAXEL SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key11884970
MDR Text Key253126637
Report NumberMW5101532
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2R8858
Device Lot Number(10)R20H11139
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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