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

Model Number	MC33904
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While performing cares it was noted that blood was backing up in the blue lumen of patient's uvc.Attempt to flush line normal saline syringe was unsuccessful.Another rn was immediately called to come to the bedside and assess.Before the other rn arrived, all clamps and lines rechecked to make sure all were appropriate and no problems were found.Tpn was changed a few hours prior to noted blood backing up and clamps were double checked immediately after tpn change with 2nd rn.Red tape was applied to clamps of syringes not being infused.The doctor was also at bedside.Other rn attempted to flush the blue lumen without success.Together we flushed the tpn line infusing in the blue lumen to find it was cracked just before the filter and was infusing fluid out of the crack of the tubing.We removed the tubing and placed all fluid to be infused in the remaining white lumen.We also changed the rate to the appropriate rate.Unable to re-create how tubing could have been compromised by clamp.

• Brand Name: ICU MEDICAL
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8763941
• Report Number: 8763941
• Device Sequence Number: 2637579
• Product Code: FMG
• UDI-Device Identifier: 00887709071155
• UDI-Public: (01)00887709071155(17)240401(30)01(10)4065904
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/01/2019
• Report Date (Section F): 07/01/2019

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: MC33904
• Device Lot Number: 4065904
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Date Report Sent to FDA: 07/01/2019