MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE ST MIDLINE CATHETER

Lot Number REDX4347

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2020

Event Type  malfunction  

Event Description

Prior to placing a midline catheter, needle and introducer/catheter are checked for patency.While doing this, it was noticed that the guidewire does not smoothly glide into the steel needle.It needed to be pushed with pressure to get through.The midline kit used- lot# redx4347.No harm reached patient as this was found out pre-procedure.Have informed and reached out to the manufacturer representative for response and/or resolution.Manufacturer response for midline catheter, powerglide st midline catheter (per site reporter).Awaiting the response from the manufacturer.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9877433
• MDR Text Key: 184848271
• Report Number: 9877433
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2020,02/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REDX4347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA