MAUDE Adverse Event Report: ICU MEDICAL CHEMOCLAVE; CHEMOCLAVE UNIVERSAL VENTED VIAL

Catalog Number CH-70-10

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  Injury  

Event Description

Icu medical chemoclave universal vented vial spike is introducing visible particulate matter into medication was when the spike pierces the vial top.Particulate matter looks like both while/offwhite "floaters" and very small, clear, bead-like spheres that sink through the solution to the bottom of the vial.This issue has been seen with multiple spikes when used on multiple different medications, multiple different mfrs' medication vials.

• Brand Name: CHEMOCLAVE
• Type of Device: CHEMOCLAVE UNIVERSAL VENTED VIAL
• Manufacturer (Section D): ICU MEDICAL; san clemente CA 92673
• MDR Report Key: 7224538
• MDR Text Key: 98540985
• Report Number: MW5074927
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 01/25/2018

1 Device was Involved in the Event

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 Expiration Date: 07/01/2022
• Device Catalogue Number: CH-70-10
• Device Lot Number: 3493845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2018
• 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
• Patient Outcome(s): Required Intervention