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

Model Number 0142075

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

Bedside nurse discovered that patient's iv line closest to the patient had blood backed up from the central line (port) into the iv tubing about 6 inches.There was a small amount of visible blood on the pt's chest and a small puddle of blood mixed with iv fluid on the sheets he was lying on.The iv pump remained running and could see that there was blood mixed with iv fluid leaking from the huber device tubing at the point where the hub of the tubing (the plastic piece that screws into the connector cap) and the thin tubing of the needle device, had become broken.The broken huber device was a 20g x 3/4 inch bard "power loc max" huber needle.Since there was a back up of blood from the pt into the tubing it was determined that there was minimal risk of contamination to the pt.(b)(6) also did not flush the blood back into the pt for this reason.He de-accessed the needle from the port.He then re-accessed the port using a 20g x 3/4 inch bard "power loc max" huber needle after cleaning/prepping the skin per policy.The newly accessed needle flushed with ease and had good blood return.Adam placed the broken device in a plastic baggy and after explaining the malfunction, turned it over to rich ramos, rn for follow up.

• 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: 10008790
• MDR Text Key: 189302149
• Report Number: 10008790
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0142075
• Device Catalogue Number: 0142075
• Device Lot Number: ASDUF021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 330 DA