MAUDE Adverse Event Report: MEDTRONIC EXTERNAL DRAINAGE AND MONITORING LUMBAR DRAINAGE KIT; CATHETER KIT

Lot Number 212851309

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  Injury  

Event Description

While md was removing spinal drain on 10/25/2017 and while withdrawing catheter slowly and deliberately, the catheter snapped off prior to exiting the spinal column.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING LUMBAR DRAINAGE KIT
• Type of Device: CATHETER KIT
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7002920
• MDR Text Key: 91187106
• Report Number: MW5073147
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 212851309
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 127