MAUDE Adverse Event Report: ICU MEDICAL, INC.; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Lot Number 4378738; 3780101; 4185077

Device Problem Break (1069)

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

Event Date 12/16/2019

Event Type  No Answer Provided  

Event Description

We have experienced multiple events in which a safeset, which is a device used perform blood sampling from a central line or an a-line, has broken.The break occurred within the syringe part of the system.The plunger separates from the hub inside the syringe barrel.

• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 9859561
• MDR Text Key: 184265579
• Report Number: 9859561
• Device Sequence Number: 1
• Product Code: DRS
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 4378738; 3780101; 4185077
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Type of Device Usage: N
• Patient Sequence Number: 1