MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number SFC6033

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/19/2019

Event Type  malfunction  

Event Description

Spiking medication vial and spike would not puncture rubber stopper/seal.Ended up pushing rubber stopper/seal through and had to waste medication.

• Brand Name: ICU MEDICAL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9197304
• MDR Text Key: 162515944
• Report Number: 9197304
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SFC6033
• Device Catalogue Number: CS-60
• Device Lot Number: 4067227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1