MAUDE Adverse Event Report: BARD CHANNEL DRAIN; SURGICAL DRAIN

Model Number 072189

Device Problems Break (1069); Product Quality Problem (1506); Defective Device (2588)

Patient Problems Respiratory Distress (2045); Perforation of Esophagus (2399)

Event Date 08/03/2016

Event Type  Injury  

Event Description

Notified on 08/16/2016 of a drain defect.Physician went to pull drain as output has diminished to an acceptable level.As the drain was being pulled, it snapped with a portion remaining in the pt.The pt went to surgery for drain removal and hematoma (not from drain) was excised.Delay in submitting report was to determine final pt outcome.See scanned pages.

• Brand Name: BARD CHANNEL DRAIN
• Type of Device: SURGICAL DRAIN
• MDR Report Key: 5935413
• MDR Text Key: 54289435
• Report Number: 5935413
• Device Sequence Number: 1
• Product Code: GBX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2016,08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: 072189
• Device Lot Number: NGAQ0649
• 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: 09/02/2016
• Distributor Facility Aware Date: 08/18/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• 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
• Patient Age: 38 YR
• Patient Weight: 75