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

Model Number LH-0031YN

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Event Description

Flushed and was removing port needle.Port needle safety did not stay on needle being pulled out and whole needle unexpectedly came out.Port needles have safety so to reduce sharp risk.

• 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: 12352769
• MDR Text Key: 267676914
• Report Number: 12352769
• 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
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0031YN
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASFRF054
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other