MAUDE Adverse Event Report: BECTON DICKINSON & COMPANY BD POWER GLIDE PRO; MIDLINE CATHETER

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Power glide catheter tip broke off in patient's vessel during placement and unable to retrieve at this time.Patient to be referred to vascular surgeon for further follow up.Fda safety report id# (b)(4).

• Brand Name: BD POWER GLIDE PRO
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BECTON DICKINSON & COMPANY
• MDR Report Key: 10810253
• MDR Text Key: 215490449
• Report Number: MW5097700
• Device Sequence Number: 1
• Product Code: PND
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 147