MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PICC PLUS STAT LOCK; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Device Problems Mechanical Problem (1384); Defective Device (2588); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Event Description

Defective picc plus stat lock, sliding post is fixed and not sliding, 2 noted found on unit.

• Brand Name: PICC PLUS STAT LOCK
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9151729
• MDR Text Key: 161074018
• Report Number: 9151729
• Device Sequence Number: 1
• Product Code: LJS
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1