MAUDE Adverse Event Report: C. R. BARD, INC. CLOSED WOUND SUCTION; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 0043610

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2021

Event Type  Injury  

Event Description

Patient s/p (status post) l2-5 posterior interbody fusion with drain placement.Removed the drain with difficulty.Assessment of drain on removal noted concern for breakage and retained portion in the wound.Pt underwent a lumbar exploration for removal of the retained portion of the drain.

• Brand Name: CLOSED WOUND SUCTION
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12445771
• MDR Text Key: 270531157
• Report Number: 12445771
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0043610
• Device Catalogue Number: 0043610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70