MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LUMBAR CATH. ACCESS. KIT (LCAK); EXTERNAL DRAINAGE ACCESSORIES

Model Number 910121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

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

This is 2 of 4 reports linked to mfg report numbers: 2648988-2021-00018, 2648988-2021-00020, 9612007-2021-00039.A facility reported that the lumbar catheter (910121) was inserted for a lumbar drain procedure and patient later developed cerebrospinal fluid (csf) leak at the insertion site.The lumbar catheter was removed and stitch was applied due to the leakage.No surgical delay was reported.

Manufacturer Narrative

The lumbar cath.Access.Kit (lcak) (910121) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The complaint is considered unverifiable and its exact root cause undetermined.The user did not report any observable product defect prior to the procedure.No information regarding insertion procedure was provided.Per risk file, the most likely cause is procedure-related.Spinal fluid may leak around the catheter and its dressing and the leakage can occur as a result of csf bypassing the insertion site, in which case the dressing will become wet.It can also occur due to placement of the catheter, damage to the drain tubing, catheter dislodgement.Dressings of the evd site need to be routinely checked, observed, and documented by hospital staff to ensure a leak has not occurred.No further investigation or corrective action is deemed required.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Type of Device: EXTERNAL DRAINAGE ACCESSORIES
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12918487
• MDR Text Key: 281671623
• Report Number: 9612007-2021-00038
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780034124
• UDI-Public: 10381780034124
• Combination Product (y/n): N
• PMA/PMN Number: K862513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1