MAUDE Adverse Event Report: ICU MEDICAL INC.; MINI DRIP IV TUBING - PRIMARY

Model Number B59006

Device Problem No Flow (2991)

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

Event Date 07/13/2016

Event Type  malfunction  

Event Description

Mini drip iv tubing - 133 in appx 17.2ml, 60 drop primary, 2 bravo24; 2 102, 24 hr use only.Pre-op nurse spiked iv fluid bag with iv tubing spike.Fluid filled iv tubing drip chamber.Fluid would not flow.Nurse confirmed all clamps open, no kinks in tubing.Attempted to flush with syringe without success.Iv fluid discarded.

• Type of Device: MINI DRIP IV TUBING - PRIMARY
• Manufacturer (Section D): ICU MEDICAL INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 5801912
• MDR Text Key: 49830785
• Report Number: MW5063458
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/13/2016

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 Expiration Date: 06/01/2021
• Device Model Number: B59006
• Device Lot Number: 3272354
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1