MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERLOC 20G X 1.5 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 0652015

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

Powerloc used for access to port.The "lock out" legs did not engage on retraction leaving the needle exposed which caused a needle stick to provider.The stick came just as the needle was being placed in sharps container so the actual needle is not available.We immediately went to the same supply bin and tested another one from what we believe is the exact same lot and the defect was duplicated.We pulled that lot and have a sample from that lot available for analysis.

• Brand Name: POWERLOC 20G X 1.5 INCH
• 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: 9720089
• MDR Text Key: 179732567
• Report Number: 9720089
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0652015
• Device Catalogue Number: 0652015
• Device Lot Number: ASDNS0074
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1