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

Catalog Number B3383

Device Problems Break (1069); Detachment Of Device Component (1104); Leak/Splash (1354)

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

Event Date 04/08/2018

Event Type  malfunction  

Event Description

A piece of the luer lock connector at the end of a trifuse broke off during inspection for tightness.Our facility has had a rash of reports related to connectors failing / leaking for this product over the past few months.Per site reporter: manufacturer has not yet responded to this latest event.

• Brand Name: SMALLBORE TRIFUSE EXT SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7432608
• MDR Text Key: 105585674
• Report Number: 7432608
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: B3383
• Device Lot Number: 3581350
• 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: 04/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.