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

Model Number MC33904

Device Problems Backflow (1064); Crack (1135)

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

Event Date 06/28/2019

Event Type  malfunction  

Event 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
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 8763941
• MDR Text Key: 150122231
• Report Number: 8763941
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709071155
• UDI-Public: (01)00887709071155(17)240401(30)01(10)4065904
• 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: 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
• Device Operator: Health Professional
• Device Model Number: MC33904
• Device Lot Number: 4065904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 DA