MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CT VACCESS W/PA CATH 8FR; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7480000

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

An implanted venous access port was implanted on (b)(6) 2020.The device was used for chemotherapy.The device was removed on (b)(6) 2022.Upon removal it was noted that the catheter tubing had shredded.All of the tubing was removed when the port was removed.Fda safety report id# (b)(4).

• Brand Name: POWERPORT CT VACCESS W/PA CATH 8FR
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 14021322
• MDR Text Key: 288789612
• Report Number: MW5108773
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7480000
• Device Catalogue Number: 7480000
• Device Lot Number: REET2787
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White