MAUDE Adverse Event Report: ICU MEDICAL, INC CHEMOLOCK VIAL SPIKE, 20MM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL-80S
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When using chemolock vial spike 20mm by icu medical it was discovered that the end spike that should go into the vial had a bent tip.This prevented the vial from being spiked.When another vial spike was used, the spike did not fully pierce through the rubber stopper of the paclitaxel, ndc (b)(4).The clamps of the vial spike on the sides of the vial were fully secured and the spike was rotated 90 degrees.When the vial was inverted though, the chemo began the leak through the rubber stopper and onto the vial spike and the hands of the technician manipulating the medication.Both the vial of chemo and the vial spike were disposed of, but other spikes of the same lot number were kept.Fda safety report id# (b)(4).

• Brand Name: CHEMOLOCK VIAL SPIKE, 20MM
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC
• MDR Report Key: 14409614
• Report Number: MW5109729
• Device Sequence Number: 6418126
• Product Code: ONB
• UDI-Device Identifier: 00887709069596
• UDI-Public: (01)00887709069596
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2022
• 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
• Operator of Device: Health Professional
• Device Model Number: CL-80S
• Device Lot Number: 5841982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown