MAUDE Adverse Event Report: ICU MEDICAL, INC 8" SMALLBORE TRIFUSE EXT, MICROCLAVE; STOPCOCK, I.V. SET

Catalog Number Z2486

Device Problems Break (1069); Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2021

Event Type  malfunction  

Event Description

While attempting to draw a blood culture from the umbilical line, the trifuse was removed.When twisting the clave, the tubing became disconnected from the connection site.The tubing was changed, and the broken catheter was placed in a biohazard bag for report.

• Brand Name: 8" SMALLBORE TRIFUSE EXT, MICROCLAVE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11677620
• MDR Text Key: 245762309
• Report Number: 11677620
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z2486
• Device Lot Number: 5065217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 DA
• Patient Weight: 1