MAUDE Adverse Event Report: NATUS NEUROLOGY INC. LUMBAR DRAINAGE CATH II KIT LAWSON; ANESTHESIA KIT

Catalog Number 82-1707

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Catheter being pulled from patient, piece did not come out and broke off.Had to be taken back to or for removal.

• Brand Name: LUMBAR DRAINAGE CATH II KIT LAWSON
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): NATUS NEUROLOGY INC.
• MDR Report Key: 8320842
• MDR Text Key: 135911370
• Report Number: MW5083856
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 01/25/2019

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 Catalogue Number: 82-1707
• Device Lot Number: 7202400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2019
• 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: 76 YR
• Patient Weight: 49