MAUDE Adverse Event Report: BECTON, DICKINSON & CO. POWER GLIDE MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F220108PT

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2024

Event Type  malfunction  

Event Description

Inserted a 20 gauge 10cm edc into pt's right brachial vein, the catheter did not slide in smooth, so the mechanism was removed.Upon investigation, the tip of the wire was no longer attached to the safety mechanism.

• Brand Name: POWER GLIDE MIDLINE CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON & CO.
• MDR Report Key: 19192887
• MDR Text Key: 341297851
• Report Number: MW5154341
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F220108PT
• Device Lot Number: REHY192Y
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1