MAUDE Adverse Event Report: ICU MEDICAL, INC. 2 GANG 4-WAY STOPCOCKS, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B99078

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 07/07/2022

Event Type  Injury  

Event Description

During ablation, patient developed air emboli.

• Brand Name: 2 GANG 4-WAY STOPCOCKS, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15083804
• MDR Text Key: 296383816
• Report Number: 15083804
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B99078
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24820 DA
• Patient Sex: Male