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

Model Number MC330027

Device Problem Break (1069)

Patient Problems Exposure to Body Fluids (1745); Hemorrhage/Bleeding (1888)

Event Date 09/11/2022

Event Type  malfunction  

Event Description

The patient was running total parenteral nutrition, lipids and antibiotics through her broviac central line.Patient was moving around her crib right before health care provider got her ready for a bath.Health care provider noticed blood dripping on both of her feet then farther examined her and saw blood starting to spread on her outfit.Health care provider quickly took her onesie off and saw that her trifuse had broken and she was bleeding from her broviac.The trifuse came apart at the main connection where the three separate lines meet.Health care provider clamped her line then took the remainder of the trifuse off to put an alcohol cap on it.The lot number of the trifuse in the medication room is lot 6010907.

• 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: 15502941
• MDR Text Key: 300775857
• Report Number: 15502941
• 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: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MC330027
• Device Catalogue Number: MC330027
• Device Lot Number: 6010907
• 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: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 330 DA
• Patient Sex: Female
• Patient Weight: 9 KG