MAUDE Adverse Event Report: BARD ACCESS SYSTEM BARD POWERPORT; PORT-A-CATH

Model Number 1608062

Device Problems Flushing Problem (1252); Occlusion Within Device (1423)

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

Event Date 03/03/2015

Event Type  malfunction  

Event Description

Port accessed, unable to flush, no blood return md notified and he ordered an iv dye study.Report shows clot in the port.Dates of use: (b)(6) 2015 still in, but not using.

• Brand Name: BARD POWERPORT
• Type of Device: PORT-A-CATH
• Manufacturer (Section D): BARD ACCESS SYSTEM
• MDR Report Key: 4616999
• MDR Text Key: 5594554
• Report Number: MW5041513
• Device Sequence Number: 1
• Product Code: LJT
• 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: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1608062
• Device Lot Number: REYK0862
• 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: 46 YR
• Patient Weight: 78