MAUDE Adverse Event Report: IV TUBE; FILTER, INFUSION LINE

Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Gas/Air Leak (2946)

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

Event Date 07/13/2019

Event Type  malfunction  

Event Description

Situation: iv filter leaking.Background: sterile primed new iv tubing for patient and discovered that iv filter was leaking.Assessment: iv filter added to primary tubing.Primed fluid through and clamped primary tubing set.Went to attach to patient 30 minutes later, noticed iv filter was leaking fluid and allowed air bubbles inside.Tubing not connected to patient and saved for review.Iv filter changed, added to primary tubing and connected to patient.Recommendation: from experience with iv tubing filter, the filter itself needs to be clamped in between priming and starting infusion.However, when medical device salesman came to discuss medical device needs, salesman stated that filters should not be doing that and must be defective.Continue to assess for defective filters.

• Brand Name: IV TUBE
• Type of Device: FILTER, INFUSION LINE
• MDR Report Key: 9071768
• MDR Text Key: 158711906
• Report Number: 9071768
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA