MAUDE Adverse Event Report: ICU MEDICAL, INC. 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET; STOPCOCK, I.V. SET

Model Number	A1001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The small-bore extension set with clamp / rotating luer (j loop) did not connect to the iv properly.The connection is not secure and there is leaking.Reportedly, this occurred twice.

• Brand Name: 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15145578
• Report Number: 15145578
• Device Sequence Number: 12042274
• Product Code: FMG
• UDI-Device Identifier: 00887709051027
• UDI-Public: (01)00887709051027
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/21/2022
• Report Date (Section F): 07/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: A1001
• Device Lot Number: 5956762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/21/2022