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

Catalog Number 142075

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/26/2018

Event Type  malfunction  

Event Description

We have had many device failures.This is representative of the problems and additional numbers affected: safety mechanism did not engage during de-access.Employee stuck index finger while de-accessing huber needle placed at facility (huber needle did not retract).Manufacturer response for huber needle, power loc (per site reporter).Phone call with manufacturer r and d rep.Not happy with results of the call.Evaluating additional huber needle manufacturers.

• Brand Name: POWERLOC MAX 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: 7663230
• MDR Text Key: 113170507
• Report Number: 7663230
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142075
• Device Lot Number: ASBZS0067,ASCQS0049,ASCNS0156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1