MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON PRATT CHANNEL DRAIN 18F; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Problems Break (1069); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2019

Event Type  Injury  

Event Description

Pt was s/p aortic valve replacement in (b)(6) 2019.Chest tubes were placed during surgery.After chest tubes were removed, a piece of the tube broke off and was left behind.Foreign body was found during f/u appt after pt had been discharged home.Pt was brought back in to surgery to remove the foreign body.

• Brand Name: JACKSON PRATT CHANNEL DRAIN 18F
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8842267
• MDR Text Key: 152894419
• Report Number: MW5088475
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 65 YR