MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0031

Patient Problem Emotional Changes (1831)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

Pediatric patient was admitted for 5 days of scheduled chemo, which she receives via her ivad (implanted vascular access device) powerport.Her port was accessed on day of admission ([redacted date]) and working well until today (day 5 of admission), when this rn was called to the bedside by the parent who noticed obvious leaking coming from the patient¿s line.The patient had ivf running at the time.The parent reported clear fluid leaking, as well as blood backflowing out the port tubing.This rn paused the fluids and assessed the line, finding an obvious crack at the end of the line where the tubing meets the needleless connecter cap.Per policy, this nurse immediately de-accessed the patient and soon after re-accessed in order to proceed with treatment.Per policy and product, these port tubings are suppose to be functional for seven days.This line cracked after five days of use without notable cause.The line was well protected by staff and parents at bedside throughout admission.This unfortunately required the patient to be re-accessed urgently, which caused both emotional stress and the need for increased staffing resources in the room.The crack also imposed a greater risk for development of a central line infection.This is not the first time a port line has cracked, and it is very concerning, especially since they are most often used on some of our most vulnerable patients.

• Brand Name: PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 18569280
• MDR Text Key: 333554002
• Report Number: 18569280
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207(17)250823(10)ASGVFC100
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Device Lot Number: ASGVFC118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA
• Patient Sex: Female