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

Model Number A1141

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2021

Event Type  malfunction  

Event Description

Nurse was at bedside and heard something hit the bedrail.9.5" smallbore trifuse ext set w/3 microclave¿ clear,nanoclave¿ (red ring), 3 ck vlvs, 4 clamps (yellow, light green, 2 white), luer lock iv set was noted to be broken just below the red med port at a point where the tubing separates, but before the intermittent infusion cap.There was no pulling on the iv tubing.

• 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: 12358919
• MDR Text Key: 267871281
• Report Number: 12358919
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A1141
• Device Catalogue Number: A1141
• Device Lot Number: 5018845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA