MAUDE Adverse Event Report: ICU MEDICAL ICU MEDICAL CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM

Model Number CL-13

Device Problem Defective Component (2292)

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

Event Date 11/29/2019

Event Type  Injury  

Event Description

Icu medical cl-13 chemolock bag spike with additive port malfunction.Fda safety report id # (b)(4).

• Brand Name: ICU MEDICAL CL-13 CHEMOLOCK BAG SPIKE WITH ADDITIVE
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION & TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL ; san clemente CA 92673
• MDR Report Key: 9426218
• MDR Text Key: 169857657
• Report Number: MW5091495
• Device Sequence Number: 1
• Product Code: ONB
• 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: 12/03/2019

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: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: CL-13
• Device Lot Number: 3601318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• 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