MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH 15FR CHANNEL DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number JP-2189

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, pt underwent bilateral total mastectomy and reconstruction with 15fr jp drain placement.On unk date, f/u visit, the drain was removed.When the drain was removed, the white tip broke off, requiring incision opening to retrieve the tip of the drain.Fda safety report id# (b)(4).

• Brand Name: CARDINAL HEALTH 15FR CHANNEL DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8777114
• MDR Text Key: 150762611
• Report Number: MW5088002
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JP-2189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2019
• 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: 48 YR
• Patient Weight: 75