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

Model Number	910121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This is 4 of 4 reports linked to mfg report numbers: 2648988-2021-00018, 2648988-2021-00020, 9612007-2021-00038.A facility reported that lumbar catheter (910121) was observed leaking on arrival to unit, dressing changed with sterile technique was done.Patient had severe headache.First cerebrospinal fluid (csf) culture was clean, then on (b)(6) 2021, neutrophils went from 2 to 77, protein / glucose was fine.Patient on ancef, culture/sensitivity showed no growing organisms.Patient was later discharged on (b)(6) 2021.
Additional 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 or Problem Description
N/a.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Common Device Name: 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: 12920170
• Report Number: 9612007-2021-00039
• Device Sequence Number: 5222982
• Product Code: JXG
• UDI-Device Identifier: 10381780034124
• UDI-Public: 10381780034124
• Combination Product (Y/N): N
• PMA/510(K) Number: K862513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown