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

Model Number	1808560
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Bard power port inserted (b)(6) 2021.During removal on (b)(6) 2021, it was noted to have a broken catheter.Distal catheter is now most likely in the vicinity of the right atrium.Fda safety report id# (b)(4).

• Brand Name: BARD POWER PORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13118674
• Report Number: MW5106383
• Device Sequence Number: 13417005
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REEZ1988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White