MAUDE Adverse Event Report: C.R. BARD, INC. CWS 400 WOUND SUCTION KIT WITH 10 FRENCH ROUND DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number 0043660

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

When attempting to remove drain from left buttock, the drain tubing broke, leaving a portion of the tubing in the patient's buttock.No bleeding or pain was observed at the site.Scheduled patient for surgery to remove.

• Brand Name: CWS 400 WOUND SUCTION KIT WITH 10 FRENCH ROUND DRAIN
• 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: 9828981
• MDR Text Key: 183272113
• Report Number: 9828981
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0043660
• Device Lot Number: NGDQ2620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2020
• Event Location: Other
• Date Report to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 65