MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERPORT IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1708000

Device Problem Material Frayed (1262)

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

Event Date 10/27/2020

Event Type  Injury  

Event Description

Surgeon was placing a chest port using bard access systems power port implantable port.Ref (b)(4), lot reeq4128.The guide wire was inserted through the needle into the subclavian, the introducer was placed over the guide wire.When the wire was being removed, it gave a small amount of resistance.The wire was carefully removed and examined.It had frayed, although all pieces were still attached, the components of the wire unwrapped.The port was subsequently placed.Xrays showed no retained foreign body and port in good position.No harm came to the patient.Fda safety report id# (b)(4).

• Brand Name: BARD POWERPORT IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 10770237
• MDR Text Key: 214346969
• Report Number: MW5097580
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026577
• UDI-Public: (01)00801741026577(17)211130(10)
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2020

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: 11/30/2021
• Device Model Number: 1708000
• Device Catalogue Number: 1708000
• Device Lot Number: REEQ4128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65