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

Model Number S1295108FD4

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

Nurse attempting to place dual lumen peripherally inserted central catheter (picc).The micro introducer from the kit was ineffective for dilating the vessel after the guide wire was placed.The first attempt was made to dilate without using the scalpel to nick the skin.The dark gray plastic appeared to retract back on itself.Then a nick was made on the patient's skin with a scalpel and another attempt was made to dilate the vessel over the guidewire.The dark gray plastic again appeared to push back and wrinkle up.Nurse stepped out of the sterile field, got a micro introducer from the picc cart along with another sterile gown and gloves and attempted with a different micro introducer and had no resistance or retraction of the second micro introducer.

• 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: 11472654
• MDR Text Key: 239449321
• Report Number: 11472654
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S1295108FD4
• Device Catalogue Number: S1295108FD4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 73