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

Model Number S1275108FD2

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Elderly female with recent history of urinary tract infection (uti) and sepsis.Procedure: while the iv team was inserting a picc line, the guidewire would not thread through the needle.Needle pulled out and another one used successfully.When the original needle was examined outside of the patient, the guidewire still was not able to be threaded in.No known harm to patient.Manufacturer response for catheter, intravascular, therapeutic, long-term greater than 30 days, powerpicc provena (per site reporter).

• Brand Name: POWERPICC PROVENA
• 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: 13731726
• MDR Text Key: 287017782
• Report Number: 13731726
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741154850
• UDI-Public: (01)00801741154850(17)230228(10)REFX1755
• 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: 03/02/2022

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: Health Professional
• Device Model Number: S1275108FD2
• Device Catalogue Number: S1275108FD2
• Device Lot Number: REFX1755
• 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: 03/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Sex: Female
• Patient Weight: 64 KG