MAUDE Adverse Event Report: BARD HEMOVAC

Model Number #0043610

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 08/14/2017

Event Type  Injury  

Event Description

A (b)(6) gentleman who underwent a multilevel decompression and fusion on (b)(6) 2017 days prior.He had a drain placed at that time if the subfascial layer.On (b)(6) 2017, upon attempt to remove the drain, it was unable to be removed.With gentle pulling pressure the drain fractured.Pt was taken to operating room on (b)(6) 2017 to surgically remove the drain.

• Brand Name: HEMOVAC
• Type of Device: HEMOVAC
• Manufacturer (Section D): BARD; covington GA 30014
• MDR Report Key: 6812824
• MDR Text Key: 83536073
• Report Number: MW5071752
• Device Sequence Number: 1
• Product Code: GCY
• 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: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: #0043610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2017
• 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): Required Intervention