MAUDE Adverse Event Report: C.R. BARD, INC. BARD CWS 400 CLOSED WOUND SUCTION KIT HEMOVAC; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Lot Number NGGY4171

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 05/12/2023

Event Type  Injury  

Event Description

Pt post hip surgery with closed wound suction kit.Upon removal, the tubing broke with remainder of tubing retained in patient.Additional surgery for removal and extra night stay in hospital.

• Brand Name: BARD CWS 400 CLOSED WOUND SUCTION KIT HEMOVAC
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 16953689
• MDR Text Key: 315549704
• Report Number: MW5117645
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NGGY4171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male