MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PORT; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number RECW2234

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2019

Event Type  Injury  

Event Description

Pt came in with a malfunctioning vap.Surgeon did a cut down to examine vap and discovered that the port catheter was severed with distal porton of port retained.Operating room surgeon on call contacted to extract the remaining portion of catheter.

• Brand Name: BARD POWER PORT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 8424709
• MDR Text Key: 139058243
• Report Number: MW5084922
• Device Sequence Number: 0
• Product Code: FPA
• Combination Product (y/n): N
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Lot Number: RECW2234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2019
• 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: 44 YR