MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC SOLO2 FT CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1295108FD

Device Problem Material Integrity Problem (2978)

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

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Bard microintroducter 5 french from picc kit with unexpected notch.Attempt to place into patient's skin prior to noticing the abnormal notch.Unable to place into patient.A new micro-introducer opened and successful placed in patient.Product ref # 1295108fd, lot # reaw1727 power picc solo ft catheter with sherlock 3cg tip positioning system (tps)stylet.Bard rep called immediately; replacement microintroducer kits sent per company.

• Brand Name: POWERPICC SOLO2 FT CATHETER
• 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: 6518044
• MDR Text Key: 73576099
• Report Number: 6518044
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1295108FD
• Device Catalogue Number: 1295108FD
• Device Lot Number: REAW1727
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 78 YR