MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. 8FR BARD GROSHONG IMPLANTED VENOUS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem Arrhythmia (1721)

Event Date 02/03/2022

Event Type  Injury  

Event Description

Vein medport, 8fr bard groshong.Catheter came apart during removal.Migrated, arrhythmias and need for transfer to a higher level of care to remove.Fda safety report id # (b)(4).

• Brand Name: 8FR BARD GROSHONG IMPLANTED VENOUS PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13480180
• MDR Text Key: 285450906
• Report Number: MW5107290
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native