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

Model Number 0142075

Device Problems Backflow (1064); Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

I entered patient's room to check in on him while parents were away and i was covering for the bedside nurse.Patient was in a crib with rails all the way up.I found the patient playing his musical instrument in the crib, and looked happy, but something told me to look at his line, so i did and found his line backflowing with blood, and patient was sitting in about 10ml of blood.I immediately stopped his fluid, and checked the cap and found his port line was broken above the cap.I have saved the port access line and placed it in the clean utility.I have informed the md and will draw blood cultures.He is now re-accessed and doing fine.

• 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: 10008794
• MDR Text Key: 189303697
• Report Number: 10008794
• 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: 730 DA