MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH 15 FR DRAIN; CATHETER, IRRIGATION

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

On (b)(6) 2019 pt underwent l6-s1 diskectomy and interbody fusion and l6-s1 posterior fusion.Discharged home with drains.At post op office visit drains removed.One drain dissociated on removal.Pt readmitted to hosp (b)(6) 2019 for removal of retained drain fragment in lumbar wound; "#15 blake drain.".

• Brand Name: CARDINAL HEALTH 15 FR DRAIN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8802919
• MDR Text Key: 151572661
• Report Number: MW5088204
• Device Sequence Number: 1
• Product Code: GBX
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR