MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA LUMBAR CATH. ACCESS. KIT (LCAK); EXTERNAL DRAINAGE ACCESSORIES

Catalog Number 910121

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the lumbar catheter (910121) ruptured at the connection site to the supplied connector on little pull while the staff repositioned the patient.Extensive disinfection and some shortening of the catheter under sterile conditions and new application of a connector from a new set was performed.It is unknown if the event led to increased surgery time; however, there was no injury to the patient.

Manufacturer Narrative

An evaluation of the lumbar catheter (910121) could not be performed because the facility lost the device.However, lot number was provided; therefore, device history records were reviewed which revealed no anomalies that could explain the reported event.Without actual device to investigate, complaint is unverifiable and the exact root cause of the reported event could not be determined.No further investigation nor corrective action is deemed required.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Type of Device: EXTERNAL DRAINAGE ACCESSORIES
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 11653269
• MDR Text Key: 264979017
• Report Number: 9612007-2021-00019
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K862513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 910121
• Device Lot Number: 0217950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR