MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO NEEDLEFREE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number D1005

Device Problem Gas/Air Leak (2946)

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

Event Date 08/06/2020

Event Type  Injury  

Event Description

Tego caps have been leaking between the clear screw adaptor and the yellow plunger part.When this occurred, air was able to enter into the patient's ij catheter with potential of serious harm to the patient.Fda safety report id# (b)(4).

• Brand Name: TEGO NEEDLEFREE CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC. ; san clemente CA 92673
• MDR Report Key: 10493770
• MDR Text Key: 205907094
• Report Number: MW5096427
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1005
• Device Lot Number: 4875056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention