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

Catalog Number CK000986

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/29/2022

Event Type  Injury  

Event Description

Picc line inserted unable to pass, began to pull catheter out to end procedure and begin to meet resistance at 37 cm.Massaged muscle and injected rest of lidocaine to area.Continued to massage area and line was then able to become dislodged and a pop sound.At the end of the tip was a small knot.Fda safety report id# (b)(4).

• Brand Name: BARD FLEXURA MICROEZ POWERPICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 15380485
• MDR Text Key: 299579122
• Report Number: MW5111917
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2022

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 Expiration Date: 07/31/2023
• Device Catalogue Number: CK000986
• Device Lot Number: REGQ1431
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female