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

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).

• Brand Name: CLEARLINK PACLITAXEL SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11884970
• MDR Text Key: 253126637
• Report Number: MW5101532
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: 2R8858
• Device Lot Number: (10)R20H11139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1