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

Model Number REF1194108D

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  Injury  

Event Description

Failed insertion of powerpicc solo catheter w/ sherlock 3cg tip positioning system stylet by picc nurse, followed by successful insertion of picc line by ir.Radiologist identified right pulmonary artery branch foreign body/wire fragment on retrospective image review and performed successful retrieval procedure of what appears to be part of the insertion sheath with orangish/golden tip noted to have multiple kinks- thought to be from powerpicc catheter, due to unrecognizable to products used in ir for picc insertion.Patient tolerated removal procedure well.When shared among system facilities- additional concerns were voiced regarding this product and kinking issues.Images available from this event.Fda safety report id# (b)(4).

• Brand Name: POWERPICC SOLO CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 13118170
• MDR Text Key: 283093146
• Report Number: MW5106366
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: REF1194108D
• Device Catalogue Number: 1194108D
• Device Lot Number: REFT2337
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male