MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER PORT ISP GROSHONG 8FR TITANIUM CUSTOM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number CP00003

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Angiogram showed leaking of contrast in the neck of the patient and no fibrin sheath.Mediport was removed and replaced with the old catheter having a hole in the site where it turned down to the ij in the neck.

• Brand Name: POWER PORT ISP GROSHONG 8FR TITANIUM CUSTOM
• 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: 17142665
• MDR Text Key: 317315559
• Report Number: 17142665
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CP00003
• Device Catalogue Number: CP00003
• Device Lot Number: REFT0908
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White