MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Lot Number REEV2356

Device Problem Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Patient has a right sided port a cath that has a lateral lumen that always had good blood return but would always flush harder than the medial.This is the same lot number as previously reports four times.

• Brand Name: POWERPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 11494248
• MDR Text Key: 240047090
• Report Number: 11494248
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 32