MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOLOCK CLOSED VIAL SPIKE (CL-80); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL-80

Device Problem Precipitate in Device or Device Ingredient (1478)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Icu medical chemolock closed vial spike (part cl80), lot number 5061988 11.01.25 using this cstd vial spike we have found spherical, clear, colorless precipitates in a number of vials that we have used this device on.I believe this is the lot number effected, as we stock products in bins after removing from shipping boxes and sometimes lots are mixed.Upon speaking with the icu medical regional manager, the company suspects that these precipitates are the medical grade silicone that is used on the spike to facilitate spiking vials and aid in the function of the product.We have been using icu medical cstd products for a number of years and have never seen this before.Fda safety report id# (b)(4).

• Brand Name: CHEMOLOCK CLOSED VIAL SPIKE (CL-80)
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC. ; san clemente CA 92673
• MDR Report Key: 11769166
• MDR Text Key: 249046831
• Report Number: MW5101140
• Device Sequence Number: 1
• Product Code: ONB
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL-80
• Device Lot Number: 5061988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• 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