MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number 125510401

Device Problem Infusion or Flow Problem (2964)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

Icu medical 7"(18cm) appx 0.69ml,ext set w/clave, clamp, rotating (ref 12551) does not clamp properly on every piv start.Blood refluxes back into catheter increasing risk of clotting off the angio catheter.Also, patient reported that the blood always backs up into the hub of angiocath.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 16910545
• MDR Text Key: 314987862
• Report Number: 16910545
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 125510401
• Device Catalogue Number: 12551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA
• Patient Sex: Female