MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD ACCESS SYSTEMS VUE IMPLANTABLE TITANIUM POWER INJECTABLE CHEST PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1708062

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  Injury  

Event Description

Chest port failure.Unable to flush or aspirate.Port function gradually deteriorated over several months until it would not longer flush.Alteplase was not helpful.Patient had previous chest port that had the same deterioration in function.Suspect medication precipitate within port.Fda safety report id# (b)(4).

• Brand Name: BARD ACCESS SYSTEMS VUE IMPLANTABLE TITANIUM POWER INJECTABLE CHEST PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 10128382
• MDR Text Key: 194523996
• Report Number: MW5094877
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Model Number: 1708062
• Device Catalogue Number: 1708062
• Device Lot Number: RECW0342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 69