MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERMIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problems Material Integrity Problem (2978); Protective Measures Problem (3015)

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

Event Date 01/17/2019

Event Type  malfunction  

Event Description

Regarding the stiffening stylet which is composed of an inner core (the mandrel) and outer coil, it is strongly suggested that the vendor consider these safety strategies: color the mandrel white; color the stylet yellow.These safety strategies will assist the proceduralist when in assessing the integrity of the stylet prior to and after use.

• Brand Name: BARD POWERMIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 8363256
• MDR Text Key: 137260159
• Report Number: MW5084261
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1