MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOLOCK UNIVERSAL VENTED VIAL SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL-70

Device Problems Contamination (1120); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Using the cl-70 adaptors and abraxane vials, the tech mixed the drug and noticed particles floating in the finished product.It was hard to tell if the particles were from the adapters coring or particles in the drug itself.The tech then mixed the same lot number of abraxane and used needle/syringe hazardous medication technique and the medication contained no particles.Using an old vial of abraxane, the tech used the cl-70 adapter again, particles were formed, making the problem most likely coring from the cl-70 adaptors.Fda safety report id# (b)(4).

• Brand Name: CHEMOLOCK UNIVERSAL VENTED VIAL SPIKE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 14187412
• MDR Text Key: 289957397
• Report Number: MW5109259
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL-70
• Device Lot Number: 5745356
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACLITAXEL PROTEIN BOUND (ABRAXANE): LOT 6200984, EXP: 01/31/2024