MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA SOLO; CATHETER, INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number S1395108D1

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/19/2021

Event Type  malfunction  

Event Description

Patient's brachial vessel was accessed using the safety needle supplied in the bard picc (peripherally inserted central catheter) kit.Blood return from the needle was positive and the guidewire was introduced through the needle.The needle was then removed from the patient's vessel, leaving the guidewire in place.I then made a tiny incision right above the guidewire to allow the dilator/introducer to be placed.I threaded the guidewire into the needle introducer and began to apply pressure to advance the introducer into the vessel.As i continued to apply pressure to the introducer, the guidewire advanced into the vessel as well.I removed the entire introducer since i didn't see the wire, and was unable to see the guidewire.I applied pressure to stop the bleeding and then ultrasound the patient's area to confirm the wire was in fact in the patient's vasculature.Guidewire was removed by interventional radiologist.Manufacturer response for picc line kit, powerpicc provena/ solo valve technology/ tps stylet (per site reporter): bard rep notified by (b)(6).

• Brand Name: POWERPICC PROVENA SOLO
• Type of Device: CATHETER, INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 11973909
• MDR Text Key: 255358638
• Report Number: 11973909
• Device Sequence Number: 1
• Product Code: LJS
• 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: 06/03/2021,04/20/2021

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: Other
• Device Model Number: S1395108D1
• Device Catalogue Number: S1395108D1
• Device Lot Number: REES0386
• 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: 06/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA