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

Model Number 1808560

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2021

Event Type  Injury  

Event Description

My implanted port broke apart inside my chest and a piece was lodged in my heart.I was in the hospital early for open heart surgery and they did a cxr the monday before surgery was scheduled and good thing they did because there obviously was a problem.Fda safety report id # (b)(4).

• Brand Name: POWERPORT IMPLANTABLE PORT GROSHONG CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 12313720
• MDR Text Key: 266494496
• Report Number: MW5103218
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2021

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
• Device Operator: No Information
• Device Expiration Date: 03/31/2023
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REDZ0908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 82