MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number ASDWS0142

Device Problem Gas/Air Leak (2946)

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

Event Date 11/18/2019

Event Type  malfunction  

Event Description

Upon accessing port, aspiration of blood noted, however significant amount of air also aspirated.Approx.10ml air for every 1ml blood noted.Patient denies pain upon flushing, no swelling at port site noted.All connections assured to be secure.Assessed by infusion center nurse.Spoke with nurse in interventional radiology, who suggested to re-access with different needle set.Upon accessing with new needle port flushed without difficultly and no air aspirated.Product and package given to patient care specialist.

• Brand Name: SAFESTEP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9586229
• MDR Text Key: 174892766
• Report Number: 9586229
• Device Sequence Number: 1
• Product Code: FPA
• 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: 12/23/2019

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: No Information
• Device Lot Number: ASDWS0142
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1