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

Catalog Number 910121

Device Problem Crack (1135)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

An integra account manager reported on behalf of the customer that there were leakages at the catheter tube of the 910121 lumbar cath.Access.Kit (lcak).The date of the incident was not specified.It was reported that cracks have occurred at the catheter connection with the luer lock connector despite careful fastening.Additional information has been requested.

Manufacturer Narrative

No device is available for analysis, no traceability information was provided and no additional information could be obtained in spite of several requests to help evaluation of the reported event.The complaint is unverifiable and its root cause could not be determined.

• 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: 7857660
• MDR Text Key: 119640441
• Report Number: 9612007-2018-00024
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K032817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 910121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1